Director, Regulatory Affairs

DescriptionWhat We Are Looking For 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. As a strategic leader, 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. The ideal candidate will combine strategic vision with hands-on execution, leveraging deep regulatory expertise to advance breakthrough healthcare solutions from concept through commercialization.What's in it for You!Competitive Pay: $177,000 - $266,000 per year. Our employees are the best part of our company. We want you to feel valued, appreciated, and included. Because of this, we make sure your hard work is recognized.Paid Leave (US ONLY): Enjoy time away from work with Company paid holidays and a flexible working schedule through our paid time off (PTO) policy.  Yep, you read that correctly. We are a Company that values you and makes sure you take time for yourself.401(k): Prepare for a secure retirement with our 401k plan, which includes an employer matching contribution.Comprehensive Health & Wellness Plans: We want to be here for our employees throughout all stages of life, which is why we offer a wide range of resources, information, and support during your career with us.Global Team: With our state-of-the-art corporate headquarters in Rock Hill, South Carolina, our global team has a presence across more than 15 countries worldwide. Experience a workplace comprised of talented individuals who are passionate about serving our customers and each other.Innovative Culture: Innovation is at the heart of what we do! Since our founding in 1986 by Chuck Hull, the inventor of 3D printing, we have continuously pushed the boundaries of what is possible with additive manufacturing. When you join 3D, you will have the opportunity to work with cutting edge technology in an innovative and collaborative cultureTalent Development: At 3D Systems, we invest in talent programs to support employees with opportunities to grow, contribute, develop, and thrive in their careers.Connection & Engagement Opportunities: We strive to cultivate an environment where our diverse global workforce can connect and thrive. Our Employee Resource Group program, Employee Recognition program, and 3D Gives Back program, are just a few examples of how you will be empowered to build connections, celebrate wins, and make a meaningful impact.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. QualificationsWhat 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 August 7, 2026#LI-MP2Job Level: Manager with Direct ReportsTravel: Yes, 25 % of the Time