Director, Regulatory Affairs (Product Development)

Arthrex; Naples (FL); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

FSA

Supplemental Insurance Plans

401(k) Matching

Annual Bonus

Wellness Program

Onsite Clinics

Onsite Lunch

Tuition Reimbursement

Parental Leave

Trip of a Lifetime

Job summary

Arthrex is seeking a Director of Regulatory Affairs – Product Development in Naples, FL to lead regulatory strategy across the product development portfolio, including NPIs, modifications, and marketing approvals.

You will oversee RA managers, partnering with Engineering, Product Management, Clinical, Operations, and Quality to drive early alignment on regulatory strategy and ensure timely approvals in the U.S., EU, and Canada. Strong leadership and regulatory expertise are essential.

Qualifications

• Bachelor's degree required; advanced degree preferred (MBA, MS).
• 12+ years in Regulatory Affairs with at least 5 years in a leadership role.
• Knowledge of FDA 510(k) and EU MDR pathways.
• Experience in design control, engineering changes, risk management, and lifecycle documentation.
• Strong leadership, communication, and cross-functional collaboration.

Responsibilities

• Lead regulatory oversight for new product development, product design and process modifications.
• Direct a team of Regulatory Affairs leaders managing segment-aligned teams.
• Serve as senior regulatory partner to Engineering and Product Management.
• Drive regulatory deliverables into design control documents and DHFs.
• Plan and execute regulatory submissions for U.S. (510(k)), Canada, and EU MDR.
• Ensure consistent regulatory decision-making and risk tolerance across segments.
• Represent Regulatory Affairs in governance, reviews and cross-functional groups.
• Oversee review of promotional materials to ensure regulatory compliance.
• Support labeling, IFUs, and promotional claims alignment with standards.
• Lead strategy for high-risk or innovation programs.
• Support development and performance of regulatory personnel.

Skills

Leadership

Regulatory strategy

FDA 510(k)

EU MDR

Design control

Risk management

Regulatory submissions

Cross-functional leadership

Education

Bachelor's degree

MBA/MS preferred

Job description

Requisition ID: 66263 Title: Director, Regulatory Affairs (Product Development)

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.

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.

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.

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.