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.

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.

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…