Regulatory Affairs Director

Arthrex•Pelican Bay, FL

About The Position

The Director, Regulatory Affairs – Product Development is responsible for leading regulatory strategy and execution across Arthrex’s product 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. This role provides strategic direction for regulatory input into design control, ensures early risk identification, and drives consistent practices across segments. The Director will ensure requirements are proactively met to enable timely product approvals in the U.S., EU, and Canada while supporting Arthrex’s innovation, design improvement, and commercialization efforts.

Requirements

Bachelor’s Degree required
12+ years of experience in Regulatory Affairs
at least 5 years in a leadership role
Demonstrated success managing regulatory personnel and overseeing strategy for product development and change management programs.
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.

Nice To Haves

advanced degree preferred (MBA, MS)

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.