VB Spine, LLC

Role Description - Develop, review, execute, and maintain validation protocols, reports, and documentation for equipment, manufacturing processes, measurement systems (MSA), and software to support new product introductions, process improvements, and sustaining activities. - Conduct periodic reviews of validated systems, equipment, processes, and software to ensure ongoing compliance and alignment with regulatory requirements and internal procedures. - Serve as the subject matter expert for validation and inspection processes, ensuring compliant implementation across internal teams and external suppliers. - Apply statistical analysis and process control methods to support management reviews, CAPAs, and quality system processes. - Lead quality system projects of moderate scope and complexity. - Collaborate closely with Operations and other business functions to ensure quality performance of products and processes. - Support the creation and maintenance of inspection methods, sampling plans, and first article inspections. - Apply foundational knowledge of manufacturing processes (milling, turning, heat treatment, passivation/cleaning) and their impact on product quality. - Execute quality deliverables related to engineering changes, product transfers, and supplier-initiated changes. - Lead the development, maintenance, and continuous improvement of internal procedures, SOPs, and work instructions. - Lead internal and supplier-driven non-conformances and manage timely closure of NCs. Qualifications - Bachelor’s degree required (Engineering discipline preferred). - Minimum of 5 years of experience in a quality role within a medical device company (or equivalent technical experience in a regulated manufacturing environment). - Strong knowledge of Quality concepts (Risk Management, CAPA, Audits, Statistics). - Knowledge of applicable regulatory requirements (ISO 13485, FDA Quality System Regulation, EU MDR, etc.) required. - Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) preferred. - Professional certifications (CQE, CRE, Six Sigma, etc.) highly desirable. - Formal investigation, root cause analysis, and process improvement skills preferred. - Ability to read and interpret engineering drawings and technical specifications preferred. - Strong project management skills and the ability to influence without authority. - Excellent verbal, written, and interpersonal communication skills. - High attention to detail, strong analytical and technical writing skills, and the ability to multi-task independently. Benefits - Comprehensive health, dental, and vision insurance. - 401(k) with company match. - Paid time off (PTO) and holidays. - Ongoing training and professional development opportunities. - Opportunity to grow within a fast-paced, dynamic company.

Role Description - Define and own a 12–24 month Data & Analytics modernization roadmap aligned with VB Spine’s business priorities and post-separation operating model, including rationalization of legacy Stryker lift-and-shift reports, datasets, and processes. - Establish the future-state analytics architecture, data platform strategy, semantic models, reporting standards, and self-service capabilities while partnering with Enterprise Applications, Infrastructure, Cybersecurity, and business functions. - Oversee delivery of dashboards, reports, datasets, and analytical models (with emphasis on manufacturing, supply chain, sales, and finance) using Power BI, Databricks, SQL, Python, and cloud technologies. - Drive analytics governance, data quality initiatives, KPI standardization, and compliance standards suitable for a regulated medical device environment. - Lead, develop, and scale a team of data analysts and engineers — including hiring, coaching, and building high-performance ways of working. - Serve as a strategic business partner to leaders across the organization, translating operational challenges into trusted data products, predictive analytics, and decision-support tools. - Advance adoption of modern analytics, automation, anomaly detection, and AI-enabled capabilities while reducing reliance on manual reporting. Qualifications - Proven experience leading Data & Analytics functions in a manufacturing, supply chain, or regulated industry (medical device preferred). - Strong technical expertise with Power BI (semantic models), Databricks, Azure Data Factory (ADF), SQL, Python, and cloud data platforms. - Demonstrated success in data modernization, report rationalization, architecture design, governance, and cross-functional stakeholder management. - Hands-on leadership style with the ability to operate at both strategic (roadmap, architecture) and execution levels (delivery, quality, team development). - Experience building and scaling analytics teams, establishing SDLC/governance processes, and driving business adoption of self-service analytics. - Bachelor’s degree in Data Science, Computer Science, Information Systems, or a related field (Master’s or advanced certifications preferred). Benefits - Comprehensive health, dental, and vision insurance - 401(k) with company match - Paid time off (PTO) and holidays - Ongoing training and professional development opportunities - Opportunity to grow within a fast-paced, dynamic company

Role Description - Administer sales compensation plans, including implementation, ongoing maintenance, performance tracking, and reporting. - Support territory design, sales alignment, and quota-planning activities. - Maintain accurate sales employee records and commercial organizational data. - Administer sales recognition, incentive, and award programs. - Develop and maintain Power BI dashboards, reports, and sales performance metrics. - Analyze sales data to identify trends, evaluate performance, and support business decisions. - Support the onboarding of indirect sales partners and administer related legal agreements and amendments. - Develop, document, and continuously improve sales operations processes. - Partner cross-functionally with Sales, Finance, HR, Legal, and other teams to support commercial initiatives. - Maintain data integrity across sales systems and assist with system enhancements, strategic initiatives, and special projects. Qualifications - Bachelor’s degree in Business Administration, Finance, Analytics, Operations, or a related field. - Advanced training or certifications in business analytics, data visualization, sales operations, or project management are a plus. - 4+ years of experience in Sales Operations, Sales Analytics, Commercial Operations, Business Operations, or a related analytical role. - Experience administering sales compensation programs and supporting territory management and quota planning. - Advanced proficiency in Microsoft Excel. - Experience with Power BI or a similar business intelligence and reporting platform. - Experience working with CRM, ERP, sales compensation, or sales planning systems. - Demonstrated ability to analyze complex data and translate findings into meaningful business insights. - Experience developing and improving operational processes and documentation. - Strong analytical, organizational, and problem-solving skills with exceptional attention to detail. - Ability to manage multiple priorities and work independently in a fast-paced environment. - Strong communication and collaboration skills with the ability to partner effectively across functions. - Sound professional judgment and the ability to handle sensitive or confidential information appropriately. Requirements - Ability to work in a standard office or remote environment, including prolonged periods of sitting and working on a computer. - Ability to communicate effectively with employees and leaders in person, by phone, and through virtual platforms. - Ability to review, analyze, and interpret sales data, policies, agreements, and employee-related documentation. - Capacity to manage multiple priorities, meet deadlines, and adapt to changing business needs. - Ability to exercise sound judgment, maintain confidentiality, and handle sensitive situations professionally. - Strong attention to detail and organizational skills. - Ability to collaborate effectively across teams while also working independently. - Ability to travel occasionally, as business needs require. Benefits - Comprehensive health, dental, and vision insurance. - 401(k) with company match. - Paid time off and company holidays. - Ongoing training and professional development opportunities. - Opportunities for growth within a fast-paced, dynamic company. Compensation Pay for this role is competitive and based on experience, with additional factors like territory requirements, qualifications, and performance taken into account. The typical pay range for this position is $70,000 – $85,000 annually, with potential for bonuses and incentives plus benefits. VB Spine reserves the right to offer compensation outside of the listed range. Final compensation is determined on a case-by-case basis and considers a variety of factors, including experience level, skill set, and market conditions.

Role Description - Participate on cross-functional product development teams to ensure US, EU, and international regulatory requirements are incorporated from the earliest stages. - Author and manage regulatory submissions (including 510(k)s and technical documentation) to secure and maintain product approvals. - Communicate FDA and other Health Authority feedback/correspondence to project teams and RA leadership. - Support post-market submissions, including progress reports and annual reports. - Conduct regulatory assessments for proposed product changes, manufacturing changes, and product transfers. - Advise teams on appropriate regulatory pathways to market. - Interface and coordinate directly with the FDA and other regulatory agencies on submissions, approvals, and compliance issues. - Review and approve Engineering Change Notices (ECNs), labeling, collateral materials, and Instructions for Use (IFUs). - Maintain regulatory information systems, US product listings, and CE Mark Technical Files / Design Dossiers. - Support internal and external audits and inspection readiness activities. - Contribute to the development and maintenance of Regulatory Affairs SOPs and processes. - Provide guidance and support to junior Regulatory Affairs Specialists and Associates. - Participate in continuous improvement initiatives within the Regulatory Affairs department. Qualifications - Bachelor’s degree (B.S. or B.A.) in a scientific area preferred; RAC certification desired. - Minimum 2+ years of experience in Regulatory Affairs within the FDA-regulated medical device industry. - Hands-on experience preparing and submitting 510(k)s and/or Technical Documentation (required). - Working knowledge of US and EU medical device regulations (international experience a plus). - Strong interpersonal, written, and verbal communication skills. - Excellent organizational, planning, and project management abilities. - Ability to work effectively in a team environment and provide leadership on projects. - Proficiency with personal computer systems and desktop office applications. - Sound understanding of scientific and regulatory principles. Benefits - Comprehensive health, dental, and vision insurance. - 401(k) with company match. - Paid time off (PTO) and holidays. - Ongoing training and professional development opportunities. - Opportunity to grow within a fast-paced, dynamic company.

Role Description - Monitor public and private tender markets for spinal implant and related services. - Prepare, compile, and submit tender documentation in compliance with legal requirements and internal procedures. - Analyse tender specifications (SWZ) and identify key requirements. - Collaborate with internal stakeholders (sales, finance, marketing, logistics, legal) to prepare competitive offers and ensure alignment with business objectives. - Coordinate communication with contracting authorities and public institutions during the tender process. - Track legislative changes in public procurement law and implement them into company processes. - Track and analyse tender results, providing management with insights, recommendations, and strategic improvements. - Drive continuous improvement of tender processes, tools, and templates in line with best practices. - Ensure adherence to corporate values, compliance, and ethical standards in all tendering activities. Qualifications - University degree (preferred fields: law, administration, economics, management). - Minimum 3–5 years of experience in tender management in the applicable country public procurement market (MedTech or healthcare experience is strongly preferred). - In-depth knowledge of applicable country public procurement law and tender procedures. - Ability to analyse complex documentation and prepare winning offers. - Advanced MS Office skills (Excel, Word, PowerPoint). - Fluency in English (written and spoken). - Strong organisational and project management skills. - Ability to work effectively under pressure and meet strict deadlines. Requirements - Accuracy, reliability, and a strong focus on detail. - High ethical standards and compliance orientation. - Ability to collaborate with multiple functions under tight timelines. - Strong communication and negotiation skills, adapted to the UK healthcare environment. - Strategic thinking combined with operational execution. - Independence and accountability for results. Benefits - Pay for this role is competitive and based on experience, with qualifications and performance taken into account. - This role is with a remote work model. While non-local candidates may apply, relocation and housing assistance are not provided, and candidates are responsible for all related expenses. Company Description VB Spine, LLC is a global patient-focused and innovation-driven spine company formed after the acquisition of Stryker’s U.S. spine implant business by the Viscogliosi Brothers. Our globally recognised identity as innovators and stewards of the spine industry reflects our commitment to patient outcomes first. With a comprehensive product portfolio and a large and growing global distribution network, VB Spine delivers specialised solutions that address critical needs in spine surgery and enhance patient outcomes. VB Spine is a strategic partner to Stryker with access to Mako Spine and Copilot. Focused on people, partnerships and operational excellence, VB Spine ensures healthcare professionals have access to the tools and resources needed to provide the highest standard of care.

Role Description - Partner closely with regional Sales teams and internal stakeholders to support daily inventory needs and ensure timely fulfillment for surgical cases. - Act as the primary interface between the regional sales team and HQ for inventory and order fulfillment coordination. - Collaborate with stakeholders to optimize field instrument and implant configurations and improve the overall order fulfillment process. - Coordinate movement of inventory across the region while ensuring accurate transactional data in CRM and ERP systems. - Review daily and weekly surgery demand and work with the Commercial Operations team to proactively address inventory constraints. - Support adoption and effective utilization of commercial systems including ERP, CRM, and Customer Complaint platforms. - Partner with the sales team to optimize product movement while minimizing cost to the organization. - Contribute to a culture of customer service excellence and operational efficiency in a fast-paced environment. Qualifications - Bachelor’s degree preferred; High School Diploma required. - Working knowledge of ERP and CRM systems (JD Edwards and Salesforce experience preferred). - Strong proficiency in Microsoft Excel (Power BI experience preferred). - Orthopedic or medical device industry experience preferred. - Excellent verbal and written communication skills with the ability to interact effectively at all levels of the organization. - Strong multi-tasking, organizational, and project management skills. - Proven ability to build effective relationships and work collaboratively in a team environment. - Proficiency in Microsoft Office Suite (Word, Excel, Access). Benefits - Comprehensive health, dental, and vision insurance. - 401(k) with company match. - Paid time off (PTO) and holidays. - Ongoing training and professional development opportunities. - Opportunity to grow within a fast-paced, dynamic company.

What You’ll Do: - Lead and develop the Commercial Operations team (Customer Service and/or Inventory Management) to deliver high levels of customer satisfaction and operational excellence - Partner with Sales leadership and Commercial Operations management to understand inventory needs and create operational plans that support revenue opportunities - Drive a culture of continuous improvement, process simplification, and best practices across order-to-cash (OTC) processes - Supervise the development and tracking of operational and fulfillment KPIs to ensure alignment and flawless order execution - Ensure effective utilization and maintenance of ERP (JDE), CRM (Salesforce), and Customer Complaint systems; support internal/external audits and maintain SOX compliance - Gather and analyze data for forecasting, planning, and logistical management of loaner and consignment inventory - Measure inventory performance monthly and lead realignment plans by product line based on metrics - Act as the primary liaison between the field sales force and internal teams to optimize instrument and implant configurations - Support new product launches, coordinate returns of old inventory, and manage logistical activities to meet customer demand - Provide coaching, performance feedback, and support talent development, succession planning, and training for team members - Collaborate with cross-functional teams to improve customer experience, resolve issues, and strengthen commercial operations What You Bring: - Bachelor’s degree required - Minimum 4 years of experience in the medical device industry (orthopedic/spine experience strongly preferred) - At least 2 years of experience in customer-facing roles - Previous people leadership or supervisory experience is highly preferred - Strong knowledge of field operations, supply chain, logistics, inventory management, and ERP systems - Excellent verbal and written communication skills with the ability to present complex information clearly - Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), JD Edwards (ERP), Salesforce (CRM), MasterControl, and PowerBI or similar reporting tools - Strong problem-solving skills with the ability to analyze issues and develop practical solutions - Ability to build effective relationships, collaborate across levels, and thrive in a fast-paced, demanding environment Why VB Spine? We believe in growing talent from within. At VB Spine, join a high-performing leadership team where you’ll directly influence commercial success, customer experience, and operational excellence in Canada — positioning yourself for growth while helping drive the future of spine care. Compensation: Pay for this role is competitive and based on experience, qualifications, leadership scope, and performance with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, people leadership experience, and local market conditions. Benefits include: - Comprehensive health, dental, and vision insurance - Retirement savings plan with company match - Paid time off (PTO) and holidays - Ongoing training and professional development opportunities - Opportunity to grow within a fast-paced, dynamic company