Director, Regulatory Affairs

Overview Join a pivotal leadership role at the forefront of innovation in personalized healthcare and additive manufacturing. In this position you will lead the development and execution of global regulatory strategies for a diverse portfolio of patient‑specific and additively manufactured medical devices, including implantable solutions, digitally enabled surgical planning technologies, and advanced manufacturing platforms. You will play a critical role in enabling safe, effective, and timely patient access to innovative therapies by navigating complex and evolving regulatory requirements across key global markets. Working closely with executive leadership and cross‑functional teams, you will drive regulatory excellence while supporting business growth, product innovation, and operational success. Based at our U.S. healthcare headquarters in Littleton, Colorado, this role offers the opportunity to influence the future of personalized medicine within a dynamic, collaborative, and growth‑focused environment. Responsibilities 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, ensuring 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. 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 life‑cycle, including post‑market obligations and change management. Qualifications 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. Benefits Competitive Pay: $177,000–$266,000 per year. Paid Leave (U.S. only): Company paid holidays and a flexible working schedule through our paid time‑off (PTO) policy. 401(k): Employer matching contribution. Comprehensive Health & Wellness Plans. Global Team: Presence across more than 15 countries worldwide. Innovative Culture: Learn from the inventor of 3D printing and work with cutting‑edge technology. Talent Development: Programs to support growth and career development. Connection & Engagement Opportunities: Employee Resource Group program, Employee Recognition program, 3D Gives Back program. Additional Information Open until: July 13 , 2026 Location: US‑CO‑Littleton Travel: Yes, 25 % of the time Type of Position: Employee 3D Systems is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, ethnicity, religion, sex, age, sexual orientation, genetic information, marital status, gender identity or national origin or because he or she is an individual with a disability or a disabled veteran, Armed Forces service medal veteran (referred to collectively as "protected veterans"). The Company also provides applicants with equal employment opportunities without regard to pregnancy, childbirth, medical needs arising from pregnancy or childbirth, and related medical conditions including, but not limited to, lactation. #J-18808-Ljbffr