QuidelOrtho

• Als Account Manager (m/w/d) tragen Sie dazu bei, dass innovative Diagnostiklösungen dort verfügbar sind, wo sie einen echten Unterschied machen. • Ausbau und Entwicklung neuer sowie bestehender Kundenbeziehungen im Krankenhaus- und Laborumfeld. • Erreichung ambitionierter Vertriebsziele bei gleichzeitig exzellenter Betreuung Ihrer Kunden im definierten Vertriebsgebiet. • Verantwortung für die erfolgreiche Vermarktung und Implementierung des gesamten QuidelOrtho-Produktportfolios mit besonderem Fokus auf die Infektionsdiagnostik und kardiologische Marker. • Erstellung individueller Angebote sowie erfolgreiche Verhandlung und Abschluss von Verträgen. • Identifikation strategischer Geschäftsmöglichkeiten bei Schlüsselkunden und Aufbau langfristiger Partnerschaften mit nachhaltigem Mehrwert für Kunden und QuidelOrtho. • Beobachtung von Markt- und Wettbewerbsentwicklungen sowie Ableitung relevanter Handlungsempfehlungen.

Role Description We are looking for a Sales Manager to join our Commercial team and lead the business development and sales activities across Calabria and Sicily. In this role, you will be responsible for driving sales growth, ensuring strong customer relationships and supporting the achievement of company sales and profitability objectives in the assigned territory. You will work closely with internal teams and external stakeholders, acting as a key point of reference for customers, opinion leaders and healthcare professionals. - Guarantees the achievement of company sales and profit objectives in the area of competence; ensures adequate coverage of the territory and effective management of its team. - Drive the achievement of sales, profitability and market share objectives in the assigned territory. - Ensure effective coverage of the territory, identifying business opportunities and developing strong relationships with customers and key stakeholders. - Maintain and strengthen relationships with Opinion Leaders, healthcare authorities, hospital administrators and general managers. - Support sellers and agents in managing complex negotiations and customer interactions. - Coordinate and develop the agencies operating in the assigned area. - Manage and develop direct resources (FAS), ensuring clear objectives, regular feedback and performance monitoring. - Prepare accurate sales forecasts and provide regular updates on business performance. - Monitor area expenses and investments, ensuring alignment with business priorities. - Promote the effective use of business tools and company processes. - Ensure compliance with HCC procedures and company guidelines. - Identify performance gaps or business risks and define corrective action plans where needed. Qualifications - Degree preferably in a technical/scientific field, or equivalent culture and experience. - 5–8 years of solid experience as a Sales Manager, ideally within the IVD, diagnostics, medical devices or healthcare sector. - Strong knowledge of the healthcare market and hospital environment. - Proven ability to manage complex negotiations and build trusted relationships with customers and stakeholders. - Experience in coordinating sales teams, agents or indirect sales networks. - Strong business acumen, analytical mindset and ability to manage forecasts, targets and territory performance. - Good communication, influencing and stakeholder management skills. - Ability to work cross-functionally and collaborate effectively with internal teams. - English intermediate level, ideally B2 / CAE. Benefits - Opportunity to contribute to a dynamic, high-performing team while shaping the market presence of cutting-edge diagnostic solutions. Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.

Title: Technical Communications Specialist II Locations: US - NY - Rochester US - FL - Pompano Beach US - OH - Athens UK - Pencoed US - CA - San Diego - Summers Ridge US - NJ - Raritan time type Full time Hybrid job requisition id R0016649 Job Description: The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Technical Communications Specialist II. This position creates and maintains technical publications about QuidelOrtho products for use by customers and field service personnel. This includes user manuals, service manuals, reagent instructions for use, technical communications, and various other forms of labeling and user aids. All publications must be error-free and compliant with FDA and other regulatory authorities worldwide. This position will be onsite in Rochester, NY. The Responsibilities - Produces technical publications and communications to support the safe and effective use and servicing of QuidelOrtho Products. - Projects may include technical manuals, online content, product labeling and instructions for use, communications and presentations delivered in various formats. - Gathers and organizes technical information from various sources. - Develops, writes, edits, manages review/approval, and proofreads complex materials for internal and external customers. - Reviews and analyzes publication/labeling effectiveness and efficiency including verification/validation. - Follows established change control procedures. - Ensures publications adhere to established standards of style and format and meet regulatory requirements. - Reviews published materials and recommended revisions or changes in scope, format, and content. - Adheres to project timelines and communicates/escalates potential impacts to project schedules. - Investigates and resolves or escalates customer complaints and concerns and responds to non-standard inquiries. - Participates in special projects as assigned. - Perform other work-related duties as assigned The Individual Required: - A minimum of an associate's degree in Technical Writing, Communications, Medical Technology, Biology or Engineering with technical writing experience or equivalent is required. - A minimum of 3 years of relevant work experience is required. - The individuals must be able to represent the Technical Publications group on cross-functional teams and be comfortable interacting with Engineering, Research & Development, Regulatory, Quality, Customer Support, IT professionals and upper levels of management. - Must be proven team player, self-motivated, able to prioritize workload with minimal supervision, manage multiple projects simultaneously and work under tight deadlines. - Excellent written and verbal communications skills and strong computer skills are required. - Experience in HTML, XML, DITA, FrameMaker, Microsoft Office and the creation of online documentation using topic-based authoring. - This position is not currently eligible for visa sponsorship. Preferred: - A bachelor's degree is preferred. - Experience working in a regulated environment - Experience with content management systems, CSS and system design - Knowledge of animation tools and Java scripting - Experience working with translated publications - Knowledge of QuidelOrtho products will be a significant advantage - Experience in website design/authoring tools The Key Working Relationships Internal Partners: Technical Subject Matter Experts in Research & Development, Technical Support, Regulatory Affairs, Quality and Compliance, Product Management/Marketing, Post Market Risk Management (PMRM), Enterprise Project Management Office (EPMO), and Information Technology (IT) External Partners: Illustrators, Translation Vendors, Print/Media Vendors and External Manufacturers (OEMs) The Work Environment Typical office environment or remote office. Exposures: Biohazardous materials, if entering lab spaces. Other factors: Some overtime may be required on a short-term basis, some travel possible (5%) The Physical Demands The work environment characteristics are representative of an office environment. No strenuous physical activity, although occasional light lifting of files and related materials is required. Sitting. Repetitive movements of hand(s). Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm. Salary Transparency The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $58,524.81 to $76,082.25 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic.

• Subject matter expertise in SAP Logistics Execution, Quality Management, Production Planning and execution modules • Cross functional integration experience with Sales Distribution, Finance and other functions • Create Business and System Process flow diagrams to document current and future business environment • Responsible for design validation, configuration, testing, implementation, end user training, functional/technical support and maintenance • Work closely with project teams to ensure integrated system solutions

Role Description QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. Key Responsibilities - Design, build, and maintain SAP security roles across multiple systems (ECC, BW, S/4HANA, BTP, Ariba). - Perform Segregation of Duties (SoD) analysis and remediation using SAP GRC Access Control. - Maintain and manage SoD rule sets, including updates, risk reviews, and alignment with business processes. - Manage end-to-end user access lifecycle (provisioning, modification, de-provisioning). - Administer and support SAP GRC Access Control modules, including: - Access Request Management (ARM) - Access Risk Analysis (ARA) - Emergency Access Management (EAM) - Ensure compliance with internal controls, audit requirements, and regulatory standards. - Actively support internal and external audits, including evidence gathering, control validation, and remediation of findings. - Perform user license analysis and optimization to ensure cost efficiency and compliance. - Collaborate with business and functional teams to design secure and efficient role structures. - Monitor and troubleshoot security-related issues across SAP systems. - Drive continuous improvement in security processes, automation, and governance. Qualifications - Minimum 5+ years of hands-on SAP Security & GRC experience. - Strong expertise in: - SAP Role Design & Authorization Concepts - SoD Risk Analysis and Mitigation - SoD Rule Set Maintenance and Governance - SAP GRC Access Control (AC 10.x / 12.x) including BRF+ and MSMP - Experience with Fiori security and catalog/role design. - Experience supporting multiple SAP environments: - SAP ECC - SAP BW - SAP S/4HANA - SAP BTP - SAP Ariba - SAP Fiori - Knowledge of user licensing models and optimization strategies. - Strong familiarity with audit processes (SOX, internal/external audits). - Strong understanding of SAP authorization objects, profiles, and role transport processes. - Experience with firefighter ID management and emergency access controls. - Ability to work independently and manage multiple priorities in a fast-paced environment. Preferred Qualifications - Knowledge of SAP Identity Management (IdM) or other Products like MS Entra Id. - Exposure to cloud security concepts within SAP BTP. - SAP Security or GRC certification is a plus. - Exposure to CPRGRC would be a plus. Soft Skills - Strong analytical and problem-solving abilities. - Excellent communication and stakeholder management skills. - Ability to translate business requirements into security solutions. - Detail-oriented with a focus on compliance and governance.

• Develop comprehensive business cases for new products, lifecycle investments, distribution expansion, and OEM partnership opportunities, including revenue, margin, and ROI modeling. • Build and maintain multi-year financial forecasts incorporating market dynamics, pricing strategy, channel margins, OEM transfer pricing, and scenario sensitivity analysis; partner with Finance to align with AOP/LRP and accountability to revenue and margin targets. • Conduct structured market segmentation including TAM/SAM/SOM modeling; assess competitive positioning; develop differentiated positioning strategies grounded in clinical value, workflow efficiency, and economic return. • Analyze regional performance trends, distributor effectiveness, pricing elasticity, installed base trends, and OEM performance to optimize market coverage and inform contract and lifecycle planning. • Own end-to-end lifecycle management across assays from concept through commercialization and maturity; develop data-driven launch strategies including revenue ramp models, channel rollout plans, inventory strategies, and milestone tracking. • Partner cross-functionally with R&D, Regulatory, Quality, Supply Chain, Operations, and Commercial teams to ensure compliant and scalable product launches. • Track post-launch performance against forecast, identify root causes of revenue or margin variance, and implement corrective actions. • Develop and execute global distribution strategy and OEM partnership framework, including partner identification, negotiation support, agreement structure evaluation (pricing, volume commitments, IP considerations, supply continuity), and KPI oversight (revenue growth, margin contribution, inventory turns, service levels).

Role Description At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Manager of Regulatory Affairs. The role manages regulatory activities related to the life cycle management of IVDs (in vitro diagnostics) and medical devices, including approval of products in the worldwide market, as directed. - Responsible for IVDR submissions and compliance to the standard. - Leads a group of RA staff who provide routine post-market support, participate on project teams, and provide guidance and strategies for regulatory issues. - Reviews and approves UE Technical Documentation Files. - Interacts with regulatory agencies regarding product registrations, licensures, and permits and supports regulatory compliance to QSR, ISO, CMDR, MDSAP, IVDD/IVDR, CFR and other worldwide regulatory requirements. - Reviews and approves labeling and Marketing/Sales literature. This position is remote eligible, with a strong preference for candidates who reside in San Diego, CA, Rochester, NY, Pompano, FL or Raritan, NJ. Responsibilities - Leads and manages a group of RA staff who support post-market activities for a designated set of medical device and/or IVD products. - Prepares regulatory documentation to support domestic and international product submissions and registrations. - Liaises with in-country regulatory partners and government agencies for regulatory submissions. - Evaluates change control documents for impact on regulatory submissions and filing requirements. - Implements, manages, and continuously improves related regulatory processes, tools, and trackers. - Reviews and approves verification and validation protocols and reports. - Reviews and approves Marketing/Sales literature and product labeling. - Manages Enterprise system entries for global trade compliance and legal distribution of product. - Establishes and/or owns regulatory affairs processes and acts as subject matter expert during inspections. - Ensures regulatory records are complete and well organized. - Develops and presents training materials for regulatory requirements and/or department processes. - Carries out duties in compliance with established business policies. - Perform other work-related duties as assigned. Qualifications - Bachelor's degree (BS/BA) in a scientific discipline. - 10 years' prior experience in the IVD (in vitro diagnostic), medical device or bio/pharma industry. - 10 years' prior regulatory affairs experience (or related educational/work experience) with progression of responsibility and leadership. - Prior experience in the preparation and submission of regulatory documentation including, but not limited to, 510(k) submissions, international registrations, and/or EU technical documentation files. - Prior experience as a project team member. - Prior direct interaction with FDA or other regulatory agencies. - Advanced knowledge of quality systems and GMP. - Advanced knowledge of current and evolving regulations for medical device (IVD) approval. - Demonstrated ability to understand and make decisions for complex situations. - Demonstrated leadership skills. - Ability to work cohesively with multi-disciplinary scientific working groups. - Excellent written and verbal interpersonal skills to influence many diverse internal/external customer groups. - Must possess a high degree of accuracy and attention to detail. - Ability to support Clinical, R&D, V&V, and PMO departments on an as needed basis in order to meet corporate objectives. - Ability to work independently and be self-motivated. - Ability to work under minimal supervision following established procedures. - Ability to handle inter/intradepartmental issues in a cooperative and diplomatic manner is required. - Ability to work on assignments of high visibility where independent action and a high degree of initiative is needed in resolving problems and developing recommendations. - Ability to work on multiple projects simultaneously. - Ability to exercise judgment within defined procedures and practices to determine appropriate action. - Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Visio. Requirements - This position is not currently eligible for visa sponsorship. Preferred - 5 years in IVD/ Medical Device industry working for a device manufacturer. - Prior direct management and/or mentorship of staff. - 5 years leadership experience. The Key Working Relationships - Interacts with Regulatory Affairs management to provide status updates, determine priorities, and receive directives. - Interacts with direct reports to manage regulatory activities and mentor them in their professional growth. - Interacts with regional Quality & Regulatory Compliance staff to determine global regulatory strategy and to exchange registration documents. - Interacts with Operations, Research & Development, Quality, Supply Chain, and other departments to assess the regulatory impact of product changes and coordinate completion of regulatory deliverables. - Works with Quality management to ensure regulatory compliance with internal quality systems. - Participates in cross-functional task forces and meetings between departments on specific issues. - Interacts with Business Unit, Marketing Communications, and Technical Publications staff in the review of advertising materials and product labeling. - Interacts with Business Unit staff in determining product strategies and business priorities. - Interacts with domestic and international agencies in securing marketing clearances, licenses and certificates (e.g., U.S. FDA and Notified Bodies) or to respond to inquiries. The Work Environment - Use of a computer is required. - Traditional office workspace or remote home office location. - On occasion, may require up to 20% of domestic/international travel. Salary Transparency The salary range for this position is $135,371.44 - $175,982.87 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. Equal Opportunity QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties.

• Responsible for revenue performance and management of field sales resources across product portfolios • Execute on strategy and tactics to maximize customer retention, revenue, and upgrade customers • Outline and reinforce expectations for menu expansion for both Account Managers and FAS • Execute and reinforce strategy and tactics to maximize new customer acquisition • Identify and execute long- and short-term plans for meeting team goals • Recruit, hire, train, develop, and manage direct reports • Establish and maintain high-level relationships with key customers

Role Description As a Field Service Engineer, you will be focusing on our customers based in Belgium, primarily around the Southwest region including areas such as the provinces of Hainaut, Namur, Brabant Wallon. Occasional customer visits outside of the regions might be required. You will be a key member of the local service team working with the Lab Specialists, Account Managers, and Backoffice colleagues. Your main responsibilities include: - Installing, maintaining, repairing, and modifying equipment (hardware & software) for clinical chemistry and transfusion medicine product lines. - Scheduling workload, modifications, and maintenance visits within territory to minimize system downtime and maintain high levels of customer satisfaction. - Meeting all designated Customer Excellence goals, supporting customer retention results. - Responding to customer requests for service support and schedules together with the Ortho Care Supervisor / Service Manager. - Training customers on their maintenance responsibilities for QuidelOrtho equipment. - Adhering to all governmental regulations/requirements as well as our own internal Compliance and Quality System. - Following QuidelOrtho complaint handling procedures relative to complaint identification, documentation, resolution, and escalation. - Contributing to opportunities for control of expenditure and revenue. - Supporting Sales activity. - Participation in the on-call rota system (Monday to Sunday), roughly once every four to five weeks. Qualifications - A degree in electronics, electro-mechanical or equivalent qualifications is highly desirable. - A minimum of 3 years’ working experience in equipment repair. - Experience in Medical devices, knowledge of hospital networks is preferred. - Ability to speak French fluently is an essential requirement. - Good English & Dutch language skills. - Ability to work remotely and independently with assistance from experienced colleagues. - Flexibility for business and customer needs. - A self-motivated team player, who can interact appropriately with peers, sales counterparts & customers. - Availability for travel around assigned region and for training purposes. - Exceptional communication skills, both written & verbal. - A customer focus mindset. - Good basic understanding of laboratory networks & an IT affinity in general is desirable. Benefits - Company Car - Bonus Plan - Attractive Benefit Pension Plan - Merits and Benefits - Service Awards - Vacation payment - Computer Glasses - Other Premiums and Programmes - Recognition Programme - Referral Programme - Employee Assistance Programme - LinkedIn Learning

• Subject matter expertise in SAP Logistics Execution, Quality Management, Production Planning and execution modules • Cross functional integration experience with Sales Distribution, Finance and other functions • Exposure to SAP Plant Maintenance, Quality Management, and Extended Warehouse Management functions is preferred • Triages Business challenges to Design and develop SAP Supply chain solutions through creating requirements definition documentation and functional specifications by accurately capturing business needs using advanced business processes • Creates Business and System Process flow diagrams to document current and future business environment, validates with the customer and aligns/informs with project stakeholders • Responsible for design validation, configuration, testing, implementation, end user training, functional/technical support and maintenance • Hands-on role to configure and maintain SAP Logistics processes supporting Process manufacturing, Inbound / Outbound Logistics execution, Shop floor Integrations, production planning/scheduling, Quality management, and Plant Maintenance • Work closely with project teams to ensure integrated system solutions • Function as key member of project teams throughout full project lifecycle (blueprinting, realization, testing, final prep, go-live, and support) including the operate phase • Provide guidance to the businesses on appropriate use of the SAP system and data • Demonstrate problem solving ability that allows for effective and timely resolution of end user tickets for system issues including but not limited to production outages, break/fix, enhancement, and end user inquiries • Maintain proper change control for the SAP system • Perform other work-related duties as assigned.