Associate Director, Device Regulatory Affairs

Biogen

2d•$160,000 - $220,000

About The Position

The Associate Director of Device Regulatory Affairs leads regulatory strategy and execution for Class III medical device submissions across the United States, European Union, and United Kingdom. The role manages a team of two global regulatory affairs staff and ensures that regulatory plans, submission content, and approval strategies are developed for high-risk device programs. As a senior regulatory representative, this role engages with health authorities, including the FDA, EU notified bodies, and UK approved bodies, to support timely and compliant responses. It works cross-functionally with Quality, Clinical, Medical Safety, Engineering, and Manufacturing to incorporate regulatory requirements into product lifecycle planning and global commercialization strategies, supporting compliance and market access for medical devices.

Requirements

Bachelor’s degree.
10+ years of experience in Regulatory Affairs for Class III implantable medical devices.
At least 5 years of experience with combination product implantable medical devices.
Experience with FDA submissions and EU MDR technical documentation.
Familiarity with global commercialization strategies for medical devices.
Strong leadership and team management skills.
Excellent communication and negotiation abilities.

Nice To Haves

Advanced degree.

Responsibilities

Lead global regulatory strategy for Class III medical device programs, including integrated regulatory pathways and submission plans.
Direct the preparation, review, and execution of major regulatory submissions for Class III devices.
Serve as a senior regulatory lead in interactions with the FDA, EU notified bodies, UK approved bodies, and other global health authorities.
Provide regulatory leadership for product development, design and manufacturing changes, labeling, clinical evidence, and risk management.
Partner with cross-functional stakeholders to translate regulatory requirements into actionable program plans and submission-ready deliverables.
Monitor evolving US and international device regulations, guidance, and standards; assess business impact and drive implementation of regulatory intelligence.
Lead and mentor global regulatory staff and cross-functional teams, providing governance, issue escalation, and inspection/readiness support.

Benefits

Medical, dental, vision, and life insurance.
Fitness and wellness programs, including fitness reimbursement.
Short- and long-term disability insurance.
At least 15 days of paid vacation and end-of-year shutdown time off from December 26 to December 31.
Up to 12 company-paid holidays and 3 paid days off for Personal Significance.
80 hours of sick time per calendar year.
Paid maternity and parental leave.
401(k) program with company-matched contributions.
Employee stock purchase plan.
Tuition reimbursement of up to $10,000 per calendar year.
Employee Resource Groups participation.
Short-term and long-term incentives, including cash bonus and equity incentive opportunities.