Director Regulatory Affairs & Quality Assurance

Title: Director or VP Title - Salary: Base + Bonus + RSU's - depending on Experience Position Summary We are seeking an experienced VP or Senior Director of Regulatory Affairs & Quality Assurance to lead global regulatory strategy and quality system execution across a growing portfolio of implantable medical devices, patient-specific technologies, additive manufacturing applications, and biomaterial-based platforms. This individual will provide strategic and hands-on leadership across regulatory submissions, quality systems, compliance initiatives, partner support, product commercialization activities, and post-market surveillance. The role offers significant visibility within the organization and will serve as a key advisor to executive leadership on regulatory and quality matters. Company Overview Come work for a innovative medical technology company focused on the development, manufacturing, and commercialization of advanced biomaterials and implantable medical device solutions. The team is expanding its portfolio of orthopedic, patient-specific, and next-generation medical technologies and is seeking a seasoned Regulatory Affairs and Quality leader to support continued growth and commercialization efforts. Regulatory Affairs Leadership Develop and execute U.S. and international regulatory strategies for:

• Conventional and additively manufactured implantable medical devices
• Patient-specific and custom medical devices
• Advanced biomaterial technologies
• New product introductions and platform expansions

Lead and manage regulatory submissions, including:

• Custom Device pathways (520(b))
• 510(k)s
• De Novo requests
• IDEs
• PMAs (as applicable)
• Q-Submissions

Serve as the primary regulatory interface with FDA and international regulatory authorities. Evaluate regulatory risks, timelines, and approval strategies related to new products, manufacturing changes, indications, and materials. Quality Systems & Compliance Own and continuously improve the Quality Management System (QMS) in compliance with:

• 21 CFR Part 820
• ISO 13485
• ISO 14971
• Applicable ASTM and industry standards

Oversee:

• Design controls
• Process controls
• Document control systems
• Supplier qualification and supplier audits
• CAPA management
• Complaint handling
• Nonconformance management
• Change control processes
• Internal and external audits

Ensure quality system readiness to support commercialization, manufacturing scale-up, and strategic partnerships. Product Launch & Lifecycle Management Provide regulatory and quality leadership supporting:

• New product launches
• Intended-use expansions
• New product configurations and indications
• Manufacturing scale-up initiatives
• Process validation activities
• Risk management and mitigation efforts

Support post-market surveillance, vigilance reporting, and ongoing regulatory maintenance activities. Collaborate closely with Research & Development, Manufacturing, Clinical, and Commercial teams to ensure regulatory alignment throughout the product lifecycle. Support implementation and maintenance of Lean Six Sigma and continuous improvement methodologies. Strategic Partnerships & Commercial Support Support regulatory and quality frameworks for:

• Licensing arrangements
• Co-development partnerships
• Supplier and manufacturing agreements
• Strategic business transactions

Participate in due diligence activities and regulatory assessments for potential partnerships and acquisitions. Provide regulatory guidance regarding product claims, intended use, and supporting scientific evidence. Cross-Functional Leadership Act as a strategic advisor to executive leadership on regulatory and quality matters. Coordinate activities with:

• External consultants
• Testing laboratories
• Contract manufacturers
• Regulatory agencies
• Strategic partners

Support executive, board, investor, and partner communications related to regulatory milestones and quality initiatives. Qualifications & Experience Required

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or related field (Master's preferred)
• 10+ years of progressive Regulatory Affairs and Quality experience within the medical device industry
• Direct experience with FDA submissions including 520(b), 510(k), De Novo, IDE, and/or PMA pathways
• Strong knowledge of FDA Quality System Regulations, ISO 13485, and risk management principles
• Experience supporting manufacturing operations, supplier quality, and audit readiness
• Demonstrated leadership experience in regulated medical device environments

Highly Preferred Experience with:

• Additive manufacturing / 3D-printed medical devices
• Patient-specific and custom medical devices
• Orthopedic, spine, extremity, or implantable medical technologies
• Biomaterials and materials-science-based technologies
• International regulatory submissions and compliance activities
• Product development and commercialization of innovative medical technologies

Leadership Profile The ideal candidate combines strong regulatory expertise with practical business judgment and the ability to work cross-functionally across engineering, quality, manufacturing, product development, and executive leadership teams. This individual will thrive in a fast-paced growth environment and bring a collaborative, solutions-oriented approach to complex regulatory and quality challenges. Apply tot his job Apply To this Job