Director, Regulatory Affairs (Product Development)

Salem Health Hospitals & Clinics; Naples, Northern (FL, KY); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Annual Bonus

Tuition Reimbursement Program

Job summary

Arthrex, Inc., headquartered in Naples, FL, seeks an experienced Director of Regulatory Affairs for Product Development to lead regulatory strategy across the portfolio, partnering with Engineering, Product Management, Clinical, Operations, and Quality to drive global compliance and timely product launches.

The role requires 12+ years in Regulatory Affairs with leadership experience and deep expertise in FDA 510(k) and EU MDR regulatory pathways.

Qualifications

• Bachelor's degree required; MBA, MS preferred.
• 12+ years of Regulatory Affairs experience with 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 across cross-functional teams.
• Ability to translate complex regulatory concepts into actionable strategies for business and technical partners.
• Ability to plan, evaluate, and improve efficiency of business processes and procedures.

Responsibilities

• Lead regulatory oversight for new product development, design changes, and related engineering changes.
• Lead a team of Regulatory Affairs leaders managing segment-aligned teams across product development lifecycles.
• Serve as senior regulatory partner to Engineering and Product Management to align on regulatory strategy and risk mitigation.
• Drive integration of regulatory deliverables into design control docs, technical files, and DHFs.
• Guide preparation and strategic planning of regulatory submissions for US (510(k)), Canada (Medical Device Licenses), and EU MDR.
• Align regulatory approaches across business segments for consistent decision-making and risk tolerance.
• Represent Regulatory Affairs in product development governance, program reviews, and cross-functional groups.
• Direct review of promotional materials and labeling to ensure regulatory compliance.

Skills

Leadership

Regulatory strategy

Cross-functional

Regulatory submissions

Education

Bachelor's degree

MBA/MS preferred

Tools

FDA 510(k)

EU MDR

Design controls

Risk management

Job description

Requisition ID: 66263

Title: Director, Regulatory Affairs (Product Development)

Join Arthrex and help shape the future of medical device innovation.

We are seeking an experienced Director, Regulatory Affairs (Product Development) for our global headquaters in Naples, FL.who will lead regulatory strategy and execution across our product development portfolio, including new product introductions, product modifications, and marketing material approvals. This high-impact leadership role partners closely with Engineering, Product Management, Clinical, Operations, and Quality teams to drive successful product commercialization and global regulatory compliance. At Arthrex, you'll work alongside industry-leading innovators dedicated to improving surgical outcomes worldwide. This is an opportunity to make a significant impact on the development and commercialization of cutting-edge medical technologies while leading a talented regulatory team in a collaborative, mission-driven environment.

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better™.

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.

Business Impact Statement:

This position plays a critical role in enabling product commercialization by ensuring timely regulatory approvals across the U.S., Canada, and EU. It directly supports revenue generation by protecting product launch timelines and ensuring compliance with evolving global regulatory requirements. The Sr. Director helps safeguard business continuity through regulatory risk mitigation and alignment with internal product development and market release goals.

Autonomy & Decision-Making:

This role operates with significant autonomy in regulatory strategy development, submission planning, and execution oversight. The Sr. Director exercises independent judgment in determining regulatory pathways, assessing risk, managing design control readiness, and driving issue resolution. The individual is accountable for regulatory performance and readiness across multiple product families and global markets, and is empowered to represent the function in high-level cross-functional discussions and business planning.

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

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
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)
• Eligible for discretionary Long Term Incentive program

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.