Description
What You Will Do
Lead Global Regulatory Strategy
• Define and execute global regulatory strategies for personalized and additively manufactured medical devices, including custom-made and patient-specific solutions and off-the-shelf components, primarily in the orthopedic space.
• Establish clear pathways for product approvals across the U.S., EU, Canada, Brazil, Australia, and other international markets.
• Interpret and operationalize evolving regulatory frameworks, including FDA guidance on additive manufacturing, EU MDR (including Annex XIII), and emerging global expectations for point-of-care manufacturing.
Enable Market Access
• Lead the planning, preparation, and submission of regulatory filings, including FDA 510(k), technical documentation under EU MDR, and international registrations.
• Determine appropriate regulatory routes (e.g., custom device exemption vs standard pathways) based on product and manufacturing model. Ensure scalable regulatory approaches that can be leveraged across multiple product types and markets.
Leadership & Execution
• Lead, mentor, and develop a small, high-performing regulatory team.
• Operate in a player-coach model providing direction while supporting execution where needed.
• Manage external partners, consultants, and regulatory service providers as needed.
Drive Cross-Functional Alignment & Executive Collaboration
• Act as a key advisor to senior leadership, providing regulatory insights that inform product development, market access, and business strategy.
• Drive alignment across cross-functional teams including R&D, Quality, Manufacturing, and Commercial.
• Lead resolution of complex regulatory challenges through structured, cross-functional problem-solving.
Regulatory Intelligence & Lifecycle and Risk Management
• Monitor and assess emerging regulations, standards, and guidance related to additive manufacturing, personalized devices, and digital health.
• Translate regulatory intelligence into actionable strategies and risk mitigation plans.
• Ensure ongoing compliance throughout the product lifecycle, including post-market obligations and change management.
Qualifications
What You Will Bring
Regulatory Expertise
• Bachelor's degree in Life Science or a related technical field; Advanced degree preferred.
• 12+ years of progressive Regulatory Affairs experience with 5+ the medical device industry, and at least 5 years in leadership roles.
• Strong knowledge of FDA and EU MDR regulatory frameworks; Familiarity with additional markets (e.g., Brazil, Australia) is a plus
• Proven track record of leading successful submissions (e.g., FDA 510(k), EU MDR technical documentation).
• Regulatory Affairs Certification (RAC) preferred.
Technical & Clinical Knowledge
• Experience with patient-specific or additively manufactured medical devices strongly preferred.
• Solid understanding of design controls, quality systems, and product development processes.
• Working knowledge of clinical applications, surgical workflows, and healthcare environments
Management
• Demonstrated ability to lead and develop high-performing teams in a global, matrixed organization.
• Experience working in lean environments, with strong ownership and accountability.
• Proven ability to prioritize competing demands and manage complex regulatory programs
• Experience managing budgets, resources, and external partners.
Communication & Influence
• Excellent written, verbal, and interpersonal communication skills.
• Ability to influence cross-functional stakeholders and executive leadership.
Strong problem-solving and decision-making capabilities, particularly in evolving regulatory landscapes.
We'll be accepting application to July 13, 2026
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