Director, Regulatory Strategy & 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

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.