Associate Director, Device Regulatory Affairs

Biogen

. Lead global regulatory strategy for Class III medical device programs, including developing integrated regulatory pathways and submission plans.

Posted 11/9/2026full-timeRemote • United StatesSenior💰 $160,000 - $220,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in leading global regulatory strategy for Class III medical devices, including FDA submissions and EU MDR technical documentation, while managing cross-functional teams and integrating regulatory requirements into product lifecycle planning.

Highest-signal resume keywords

Regulatory Affairs ExperienceClass III Medical DevicesFDA SubmissionsEU MDR Technical DocumentationLeadership and Team Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentRegulatory Submission PreparationRisk ManagementClinical Evidence AssessmentRegulatory Intelligence Monitoring

Soft Skills

Excellent CommunicationNegotiation Abilities

Industry Keywords

Global Health AuthoritiesCombination ProductsProduct Lifecycle PlanningGlobal Commercialization StrategiesCross-Functional Collaboration

About the role

Key responsibilities & impact

Lead global regulatory strategy for Class III medical device programs, including developing integrated regulatory pathways and submission plans.
Direct preparation, review, and execution of major regulatory submissions for Class III devices.
Serve as a senior regulatory lead for interactions with FDA, EU notified bodies, UK approved bodies, and other global health authorities.
Provide regulatory leadership for product development, design changes, 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, assessing business impact and driving implementation of regulatory intelligence.
Lead and mentor global regulatory staff and cross-functional teams, providing governance, issue escalation, and inspection/readiness support.
Manage a team of 2 global regulatory affairs staff.
Integrate regulatory requirements into product lifecycle planning and global commercialization strategies.
Serve as a senior regulatory representative in interactions with FDA, EU notified bodies, and UK approved bodies.

Requirements

What you’ll need

Bachelor’s degree and 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.
Biogen is an E-Verify Employer in the United States.

Benefits

Comp & perks

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation 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