Getinge

Role Description The Medical Science Liaison is primarily responsible for effectively communicating the clinical utility of the Paragonix Organ Preservation Systems and engaging in thorough scientific discussions with new and existing customers. This position will support the commercial team in developing strong relationships with Key Opinion Leaders (KOLs) and clinical decision makers across the field of solid organ transplantation. - Communicate and reinforce the clinical utility of the Paragonix suite of organ preservation systems across solid organ transplantation (including heart, lung, liver, kidney, and pancreas transplant). The initial focus of this position will be abdominal organ transplantation. - Differentiate Paragonix products through excellent presentation and communication skills, with the ability to deliver high-quality clinical presentations and engage in scientific discussions with external transplant professionals. - Develop strong and productive working relationships with KOLs in the field of transplantation including surgical directors, medical directors, transplant physicians, and allied health professionals. - Develop expertise in the supporting background literature in the areas of solid organ transplantation and keep abreast of current developments in the literature. - Function as the primary clinical resource for Regional Territory Managers (RTMs) to help support adoption and expanded use of Paragonix organ preservation systems. - Support Paragonix initiatives at clinical and scientific meetings, including national conferences. - Support Clinical Operations needs with field support at transplant centers participating in the GUARDIAN-registries (sponsored by Paragonix Technologies). - Comply with all corporate policies, standards of conduct and maintain all administrative functions such as expense reports, lead follow-up in accordance with corporate directives in a timely manner. Qualifications - Minimum of a BS degree in physical, biological, nursing, or clinical laboratory science required; BSN, Masters, PharmD, or PhD preferred. Equivalent combination of education and experience will also be considered. - Minimum 2 years of organ transplant experience (clinical or industry). Requirements - This role is a remote (US) position with expectations of regular in-person customer visits. - Must be willing to travel domestically and/or internationally, including overnights and air travel, up to 70% of the time. - Excellent understanding of abdominal transplant clinical nuance. - Emotional intelligence, ability to persuade, relationship building, communication, listening, organization, critical thinking, and collaboration skills. - Demonstrated ability of working in a fast-paced, matrixed organization that requires quick response to changing needs. - Excellent interpersonal relationships. - Excellent presentation and communication skills. - US BASED SALARY - The minimum base salary for this position is $160,000 and the maximum salary is $180,000 plus 20% in annual bonus. Benefits - Health, Dental, and Vision insurance benefits. - 401k plan with company match. - Paid Time Off. - Wellness initiative & Health Assistance Resources. - Life Insurance. - Short and Long Term Disability Benefits. - Health and Dependent Care Flexible Spending Accounts. - Commuter Benefits. - Parental and Caregiver Leave. - Tuition Reimbursement.

Role Description The Product Specialist supports the PM/MM in managing the relevant product line. He/she acts directly on an assigned territory ensuring that marketing strategies are executed correctly to reach established sales targets. He/she monitors competitors and retrieves information from the field to share with the PM/MM. Job Responsibilities and Essential Duties - Field Marketing Activities (50%) - Perform promotional product demonstration - Perform training to salesforce and support them throughout the entire sales process - Show and describe the product line to customers during congresses and meetings - Help PM/MM in the field activities related to new products launch - Manage product quality activities with salesforce (i.e., field actions) - Tender Management (20%) - Analyze and prepare technical documentation necessary to participate in public tenders - Define technical configuration in coordination with the Sales department - Transmit the relevant documentation for the tender to the T&O Department - Marketing strategies & activities (20%) - Help PM/MM develop and implement marketing plans and related changes to reach established sales targets - Help PM/MM collaborate with international colleagues to share knowledge, exchange experiences, and address issues - Help PM/MM launch new products to achieve agreed sales and profit objectives - Help PM/MM check validated brochures and marketing material translation - Help PM/MM in managing DEMO products pool - Help PM/MM maintain the salesforce competence at a high and appropriate level - Help PM/MM create and check order configuration to send to production - Market Analysis (10%) - Monitor competitors and retrieve information from the field to share with the PM/MM - Help PM/MM adjust marketing strategy and execute it to meet changing markets and competitive conditions - Help PM/MM maintain the local pricing strategy within international guidelines Qualifications - Bachelor’s degree in related field - Minimum 2 years of experience as Product Specialist or in a similar role - Experience in the operating room environment is a strong plus - Fluent Italian and professional level of English (written and spoken) Requirements - Microsoft Office package - Complete product line knowledge and preparation - Good knowledge of the product line's target market - Adequate presentation and communication skills (verbal and written) - Competence in the development of sales tools and collaterals - Customer satisfaction oriented - Team oriented - Interpersonal relationship skills - Open-minded and creative - Outstanding organizational skills - Positive thinking attitude Contract Details - Full-time permanent contract (40 hours per week) - National Collective Labor Agreement: Tertiary, Distribution and Services - Compensation package: 39.000 - 48.000 € gross + company car (also for private use) - Expected start date: as soon as possible, by September Benefits - Comprehensive healthcare solutions and wellness programs - Continuous learning, internal mobility, and career development opportunities - Initiatives and tools to support a healthy balance between professional and personal life

Role Description QRC Specialist provides support to the QRC Director UKI for maintaining and improving a compliant Quality Management System (ISO9001, ISO 13485), including audits, CAPAs, regulatory monitoring, product registrations, and ensuring adherence to quality and compliance targets. - Support in maintaining and controlling a Quality Management System based on ISO9001, ISO 13485 and Global procedures - Assisting in the investigation of NC handling in various tracking systems and following up on the corrective actions - Assist in Field Safety Corrective Actions (FSCA) - Support and/or perform internal and external audits and support the QMS Manager with the follow-up of these audits - Support on all related CAPA’s and non-conformities - Assisting in monitoring and maintaining quality and compliance targets - Preparing and analyzing information for the purpose of Management Review - Stay alert on all regulatory changes, analyze the changes, and communicate, implement the applicable requirements - Support in ensuring products are registered with the authorities (MHRA) within the required deadlines - Assist in any Regulatory changes, analyze, communicate, anticipate and implement the applicable requirements - Interact with the Authorities to provide requested feedback - Support the sales organization with the complaint handling, ensure that the SSU’s are recording the complaints through the associated tools, within the time limits - Supporting the implementation of Field actions and Quality Holds - Support and organize trainings and awareness to the SSU’s in Regulatory Affairs, Post-Market Surveillance, QMS - Collecting and monitoring KPIs across the Quality Management System Qualifications - A degree is desirable but not essential - Experience working with Quality Management System required - Experience in the medical device industry is desirable - Knowledge of ISO 13485 / ISO 9001 - Knowledge of NC and CAPA process desirable - Excellent language skills in English – verbal and written Requirements - Good knowledge of Microsoft packages - SharePoint, E-learning, TrackWise experience is desirable - Knowledge in Medical device regulation (MDR, UKMDR), MDD and EUMDR is desirable - Ability to work unsupervised / remotely - Ability to work well with others across UK and Ireland and other global locations Company Description With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Role Description The Project Manager – Quality and Regulatory will lead and coordinate projects aimed at Quality Management System (QMS) enhancement initiatives. The project manager will serve as the primary driver of project(s) execution across a group of QMS workstreams, coordinating cross-functional teams and ensuring delivery against defined milestones. Key deliverables include: - Development of project timelines - Project team assembly - Managing the schedule - Maintaining effective communication through the project This position is defined term for approximately 12 months. While the role is remote, candidates should reside in Eastern Standard Time. Qualifications - Expert-level working knowledge of FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR) - Strong applied understanding of ISO 13485:2016 QMS requirements throughout the device lifecycle - Demonstrated hands-on experience with QMS process areas - Familiarity with ISO 14971 risk management principles and FDA 510(k) / Class II submission processes - Demonstrated experience leading complex, multi-workstream projects within a formal project management framework - Proven ability to develop and manage integrated project schedules, RAID logs, status reports, and steering committee materials - Experience managing cross-functional teams in a matrixed organizational environment - Excellent written and verbal communication skills - Proven ability to influence, align, and lead cross-functional stakeholders - Strong organizational skills; detail-oriented with a track record of delivering on schedule in regulated environments Requirements - Bachelor’s degree in engineering, Life Sciences, Quality, Business Administration, or a related field required - Master’s degree or advanced technical credential a plus - Minimum 5 years of experience in project or program management roles within the medical device industry - Minimum 3 years of direct, hands-on experience implementing or managing QMS projects under FDA 21 CFR Part 820 and/or ISO 13485 - Experience in supporting or leading QMS projects for companies undergoing FDA Class I and/or Class II classification transitions is strongly preferred - PMP (Project Management Professional) certification is highly desired Benefits - Health, Dental, and Vision insurance benefits - 401k plan with company match - Paid Time Off - Wellness initiative & Health Assistance Resources - Life Insurance - Short and Long Term Disability Benefits - Health and Dependent Care Flexible Spending Accounts - Commuter Benefits - Parental and Caregiver Leave - Tuition Reimbursement

Role Description Strategic and operational responsibility for leading and managing all aspects and activities associated within the purchasing function. Support strategic/transactional sourcing processes for all direct and indirect spend, integrate procurement standards and activities for top suppliers, and responsible for delivering annual savings targets for the organization. Responsible for managing the supply base to include supplier performance and new sourcing activities. Support manufacturing operations, R&D, manufacturing engineering and other relevant functions. Site purchasing representative for coordinating/executing ACT and Getinge Group Purchasing activities. Provides direction to “on site” Global Segment (Plastics) Sourcing Specialist to execute Getinge’s purchasing and supplier global strategies. Qualifications - Bachelor’s degree in Operations Management or Business preferred, or equivalent. - Minimum of six years of relevant functional experience in Sourcing, Purchasing, or Procurement required. - Must be able to communicate (read, write, and speak) English. - Demonstrated ability to lead a team to deliver expected outcomes. - Knowledgeable of commodity strategies including spend and supply market analysis, cost savings methodology, requirements planning and performance reporting. - Understanding of industry Quality Control Standards (ISO, AQL) and/or experience in a highly regulated environment. - Strong working knowledge of MS Office applications are required (Word/Excel). - Knowledge of Oracle a plus. Requirements - Professional certification(s) preferred. - Able to establish and maintain relationships to motivate direct reports and peers to achieve objectives. - Ability to deal effectively with all employees and external business contacts. - Ability to communicate effectively, both verbally and in writing. - Ability to completely maintain confidentiality and discretion in business relationships and exercise sound business judgment. - Ability to interpret, understand and challenge technical documents (materials specifications, drawings, defect analysis, etc.). - Experience developing and leveraging strategic business relationships with vendors/suppliers. - Demonstrated negotiation and technical skills. - Highly effective problem-solving skills. - Highly effective skills at analyzing operations data and developing and recommending programs that support Company strategies. Benefits - Health, Dental, and Vision insurance benefits - 401k plan with company match - Paid Time Off - Wellness initiative & Health Assistance Resources - Life Insurance - Short and Long Term Disability Benefits - Health and Dependent Care Flexible Spending Accounts - Commuter Benefits - Parental and Caregiver Leave - Tuition Reimbursement

Role Description As the Senior Manager, Pricing Strategy & Analytics (North America), you will lead regional pricing strategy, governance, and advanced analytics to improve price realization and margin performance across North America. This role serves as a key advisor to North America Commercial and Finance leadership, translating business priorities into pricing guardrails, decision frameworks, and actionable insights. Reporting to the Sr. Director, North America Pricing, Governance & Analytics, this role offers high visibility and cross-functional collaboration across the organization. Closely partners with global Sales Pricing functions and global Getinge factories. Job Responsibilities and Essential Duties - Develop and execute pricing strategies, including setting targets and margins across product lines and markets in partnership with Global Pricing, Commercial Operations and Sales. - Ensure pricing consistency and alignment through cross-functional collaboration. - Lead enhancements to pricing tools, processes, and systems to drive operational excellence. - Advance analytics to improve pricing insights and decision-making. - Provide guidance on pricing strategy across the product lifecycle. - Conduct competitive pricing analysis to identify risks and opportunities. - Partner with IT to optimize CPQ system functionality and ensure process compliance. - Monitor performance of pricing initiatives and track impact against objectives. - Manage monthly pricing dashboards and analyze drivers of price performance across North America agreements. - Responsible for leading and building a performance-driven culture in Getinge’s global Pricing strategy. - Coordinate and communicate Pricing Governance activities, including agendas, minutes, and approval follow-ups with the NA Leadership team. - Collaborate with Global Pricing and regional sales teams to develop pricing strategies for new product launches. - Partner closely with NA Finance to monitor pricing performance and identify trends. Qualifications - Bachelor’s Degree in Finance, Marketing, Business Administration, Analytics, or a related field; MBA preferred. - A minimum of 15 years of experience in pricing within a B2B setting, with a proven track record of success. - A minimum of 10 years of Medical Device experience in Pricing, Finance, Marketing Strategy and related background. - Proven experience and track record of success driving pricing consistency and alignment across North America markets and product portfolios. - Proven ability to influence senior stakeholders and drive cross-functional alignment without direct authority. - Strong strategic thinking and leadership skills with the ability to communicate effectively to drive business results. - Experience in pricing strategy development and implementation in a North America environment. - Excellent communication, facilitation, and stakeholder management skills, with the ability to influence at all levels of the organization. - Knowledge of value-based pricing concepts and methods; comfort working with competitive benchmarks and market intelligence. - Ability to operate effectively in a fast-paced, changing environment and manage multiple priorities with strong attention to detail. - Strong problem-solving skills and ability to work in a fast-paced, dynamic environment. - Highly proficient (super user) in Microsoft Office (Excel, PowerPoint, Word, Outlook); comfort working with PowerBI, data visualization and analytics tools. - AlphaSense knowledge preferred. Requirements - The base salary for this position is a minimum of $155,000 and a maximum of $180,000, plus 25% bonus. Company Description With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Role Description As the Senior Manager, Pricing Strategy & Analytics (North America), you will lead regional pricing strategy, governance, and advanced analytics to improve price realization and margin performance across North America. This role serves as a key advisor to North America Commercial and Finance leadership, translating business priorities into pricing guardrails, decision frameworks, and actionable insights. Reporting to the Sr. Director, North America Pricing, Governance & Analytics, this role offers high visibility and cross-functional collaboration across the organization. Closely partners with global Sales Pricing functions and global Getinge factories. Job Responsibilities and Essential Duties - Develop and execute pricing strategies, including setting targets and margins across product lines and markets in partnership with Global Pricing, Commercial Operations and Sales. - Ensure pricing consistency and alignment through cross-functional collaboration. - Lead enhancements to pricing tools, processes, and systems to drive operational excellence. - Advance analytics to improve pricing insights and decision-making. - Provide guidance on pricing strategy across the product lifecycle. - Conduct competitive pricing analysis to identify risks and opportunities. - Partner with IT to optimize CPQ system functionality and ensure process compliance. - Monitor performance of pricing initiatives and track impact against objectives. - Manage monthly pricing dashboards and analyze drivers of price performance across North America agreements. - Responsible for leading and building a performance-driven culture in Getinge’s global Pricing strategy. - Coordinate and communicate Pricing Governance activities, including agendas, minutes, and approval follow-ups with the NA Leadership team. - Collaborate with Global Pricing and regional sales teams to develop pricing strategies for new product launches. - Partner closely with NA Finance to monitor pricing performance and identify trends. Qualifications - Bachelor’s Degree in Finance, Marketing, Business Administration, Analytics, or a related field; MBA preferred. - A minimum of 15 years of experience in pricing within a B2B setting, with a proven track record of success. - A minimum of 10 years of Medical Device experience in Pricing, Finance, Marketing Strategy and related background. - Proven experience and track record of success driving pricing consistency and alignment across North America markets and product portfolios. - Proven ability to influence senior stakeholders and drive cross-functional alignment without direct authority. - Strong strategic thinking and leadership skills with the ability to communicate effectively to drive business results. - Experience in pricing strategy development and implementation in a North America environment. - Excellent communication, facilitation, and stakeholder management skills, with the ability to influence at all levels of the organization. - Knowledge of value-based pricing concepts and methods; comfort working with competitive benchmarks and market intelligence. - Ability to operate effectively in a fast-paced, changing environment and manage multiple priorities with strong attention to detail. - Strong problem-solving skills and ability to work in a fast-paced, dynamic environment. - Highly proficient (super user) in Microsoft Office (Excel, PowerPoint, Word, Outlook); comfort working with PowerBI, data visualization and analytics tools. - AlphaSense knowledge preferred. Requirements - The base salary for this position is a minimum of $155,000 and a maximum of $180,000, plus 25% bonus. Benefits - Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process. Company Description With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Role Description The Senior Manager, Regulatory Affairs, provides regulatory strategy and execution leadership for U.S., EU, and Rest of World (ROW) market access and compliance to enable safe, compliant market access for a broad Surgical Workflows Infection Control Consumable (SWICC) products portfolio. - Ensures consistent compliance with U.S. (FDA), EU MDR (2017/745), and applicable global regulations. - Collaborates with product development, quality, operations, marketing, clinical affairs, and global regulatory teams. - Serves as a primary point of regulatory accountability for cross-functional leadership engagement and health authority interactions. Qualifications - Must have FDA and Notified Body Audit Experience. - Deep technical knowledge of 21 CFR 820/QMSR, 21 CFR 807, 803, 806; EU MDR (2017/745); ISO 13485 and ISO 14971. - Strong strategic mindset with ability to align regulatory strategy with engineering, quality, and business objectives. - Excellent communication skills, influencing capability, and experience working in global, matrixed environments. - Advanced regulatory writing and documentation oversight capability. - Demonstrated ability to mentor and develop a high-performing staff. - Ability to multi-task in a fast-paced environment. - Excellent analytical, troubleshooting, decision making, organizational, time management and communication skills. Requirements - Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related discipline (Advanced degree preferred). - Minimum 8–10+ years of progressive regulatory experience in the medical device field. - Demonstrated experience leading FDA Class I and II submissions (e.g., 510(k)) required. - Direct engagement with FDA required; experience interacting with EU Notified Bodies required. - RAC certification or equivalent preferred. Benefits - Health, Dental, and Vision insurance benefits - 401k plan with company match - Paid Time Off - Wellness initiative & Health Assistance Resources - Life Insurance - Short and Long Term Disability Benefits - Health and Dependent Care Flexible Spending Accounts - Commuter Benefits - Parental and Caregiver Leave - Tuition Reimbursement

Role Description To expand market share for the Paragonix Product & Service portfolio by promoting, selling, and servicing within assigned territory. Paragonix seeks candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, services, processes, and systems by being accountable, having a voice, and taking action. Job Responsibilities and Essential Duties - Achieve a minimum of 100% monthly, quarterly, and annual sales targets. - Maintain and increase ASP where applicable, gain market share quarter over quarter and year over year within aligned territory. - Differentiating Paragonix products & services from the current standard of care and competitive products. - Call points will include but are not limited to adult and pediatric transplant surgeons, medical directors, medical transplant physicians, fellows, transplant administration, C-suite, and OPOs. - Develop and leverage relationships with multiple stakeholders across the transplant ecosystem, including but not limited to: Surgeons, Medical Directors, Fellows, Administrators, Coordinators, Buyers, and OPOs. - Differentiating Paragonix products by discussing clinical data; conducting in-services & training; attending local, regional, and national conferences, and supporting cases on a regular basis. - Cross-sell Paragonix full product portfolio. - Communicate territory needs, trends, and problems to the Area. - Maintain and track field inventory and facilitate efficient customer inventory. - Facilitate communication with AP on past due items. - Comply with all corporate policies, standards of conduct and maintain all administrative functions such as expense reports, utilization of CRM, lead follow-up in accordance with corporate directives in a timely manner. - Collaboration with clinical, services, and internal teams to achieve company objectives. Qualifications - Minimum A./B.S. - Minimum 3 to 5 years disposables medical device sales experience, transplant, and physician preference items preferred. Requirements - This role is an outside sales remote (US) position with expectations of regular in-person customer interactions. - Must be willing to travel domestically and/or internationally, including overnight and air travel, up to 60% of the time. - Must be willing to be available after-hours and, at times, formally on-call related to the nature of conducting business in the 24-7 transplant space. - Must be able to carry bulky items, stand for extended periods of time, and work prolonged, unpredictable hours in high-stress environments such as operating rooms. - Excellent Sales, Relationship Building, Communication, Listening, Organization, Critical Thinking, and Collaboration skills. Benefits - Health, Dental, and Vision insurance benefits. - 401k plan with company match. - Paid Time Off. - Wellness initiative & Health Assistance Resources. - Life Insurance. - Short and Long Term Disability Benefits. - Health and Dependent Care Flexible Spending Accounts. - Commuter Benefits. - Parental and Caregiver Leave. - Tuition Reimbursement.

Role Description Responsible for leading Getinge Global CAPA Continuous Improvement activities supporting Getinge by addressing three core challenges: Competency, Culture and Complexity with the goal to build expertise, foster shared accountability and simplify processes to enable faster, more effective problem resolution and continuous improvement across the Getinge organization. The position supports Getinge’s products under the Acute Care Therapy, Surgical Workflow and the Life Science business areas. Job Responsibilities and Essential Duties - Lead cross functional teams to upgrade and improve performance of Getinge’s end-to-end CAPA System (NC and CAPA). - Assess health of system (compliance, efficiency, performance) and manage a portfolio of improvement projects. - Support Getinge Entities in audit (internal and external) activities. - Engage with stakeholders, including customers and suppliers, to gather feedback and ensure that their requirements are integrated into the Getinge CAPA system. - Ensure compliance with the company’s Quality System policies and procedures. - Conduct training sessions and workshops and serve as a CAPA coach to educate resources on the CAPA System. - Participate in industry & FDA conferences to stay current on enforcement priorities and upcoming changes. - Develop and manage personnel. Internal and External Contacts/Relationships - Quality & Regulatory Affairs Senior Leaders - Global Process Caretakers - Functional leads in BA (ACT, SW, LS) - Global Sales & Service and Operational Services (Logistics) - Local Quality Managers (LQMs) - Global Regulators – FDA, Notified Bodies, Competent Authorities, etc. Qualifications - Master’s Degree in a relevant field (e.g., Business Administration, Quality Management, or other related science discipline or equivalent combination of education and experience is required). - A minimum of 10 years related experience in medical device quality process areas. - Subject matter knowledge in CAPA and NC processes (CAPA System). - Strong understanding of Quality Management System operations and application of Global Regulations, ISO standards and management controls. - High level of influence and mediation skills; can facilitate bringing people from different perspectives to consensus. - Internal and External Audit Experience; participation in observation response writing and/or working groups. - Consent decree and remediation activities. - Strategic QMS thinker with excellent analytical and problem solving skills. - Demonstrated ability to work collaboratively in a cross-functional, matrixed environment. - General understanding of reporting tools (Crystal Reports, Power BI). - Effective written and verbal communication, including technical writing skills. - Proficiency with Microsoft Office Suite (Word, Excel, Outlook, Teams, Sharepoint, Powerpoint). Preferred Qualifications - Trackwise application experience. - Certification in quality management (e.g., Six Sigma, CQM, ISO Lead Auditor). Compensation - The base salary for the position is a minimum of $183,000 and a maximum of $210,000, plus annual bonus of 30%. Company Description With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.