Director, Regulatory Affairs (Product Development)

Main Objective

The Director, Regulatory Affairs – Product Development is responsible for leading regulatory strategy and execution across Arthrex’s product development portfolio, including new product introductions (NPIs), product modifications, and marketing material approvals. This individual will oversee a team of Regulatory Affairs managers aligned with major business units and serve as the senior regulatory partner to Engineering, Product Management, Clinical, Operations and Quality leadership.

Essential Duties And Responsibilities

• Lead regulatory oversight for new product development, product design and process modifications, and related engineering changes.
• Lead a team of Regulatory Affairs people leaders who manage segment-aligned teams and provide regulatory support across the product development lifecycle across all business segments.
• Serve as the senior regulatory partner to Engineering and Product Management, ensuring early alignment on regulatory strategy and risk mitigation during design and development.
• Drive integration of regulatory deliverables into design control documentation, technical files, and DHFs.
• Guide the preparation and strategic planning of regulatory submissions for the U.S. (510(k)), Canada (Medical Device Licenses), and the European Union (CE Marking under MDR).
• Align regulatory approaches across business segments to ensure consistency in decision-making, risk tolerance, and execution practices.
• Represent Regulatory Affairs in product development governance, program reviews, and cross-functional working groups.
• Direct the regulatory review and approval process for promotional and marketing materials related to new and modified products.
• Support the review and refinement of labeling, instructions for use (IFUs), and promotional claims to ensure compliance with global regulatory standards.
• Lead regulatory strategy for innovation-focused or high-risk programs in collaboration with internal and external stakeholders.
• Support the development and performance of regulatory personnel, including leadership coaching and succession planning.
• Contribute to inspection readiness, regulatory audits, and internal quality system improvement initiatives.

Education And Experience

• Bachelor’s Degree required; advanced degree preferred (MBA, MS) preferred.
• 12+ years of experience in Regulatory Affairs with at least 5 years in a leadership role.
• Demonstrated success managing regulatory personnel and overseeing strategy for product development and change management programs.

Knowledge and Skill Requirements/Specialized Courses and/or Training

• In-depth knowledge of FDA 510(k) and EU MDR regulatory pathways.
• Expertise in design control, engineering change processes, risk management, and product lifecycle documentation.
• Strong leadership, communication, and collaboration skills across cross-functional teams.
• Ability to translate complex regulatory concepts into actionable strategies for business and technical partners.
• Ability to plan, evaluate, and improve the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output.
• Experience in regulatory review of labeling and promotional materials in compliance with FDA, FTC, Health Canada, and EU advertising standards.