Associate Director, Global Regulatory - Class III Devices

Biogen; Boston (MA); On-site; USD 160,000 - 220,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Fitness reimbursement

Disability insurance

Paid vacation

Company holidays

Parental leave

401(k) matching

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen is seeking an Associate Director of Device Regulatory Affairs to lead regulatory strategies for Class III medical devices across the US, EU, and UK, directing major submissions and interactions with FDA and notified bodies. You will mentor a small global team and partner with Quality, Clinical, Engineering, and Manufacturing to align regulatory plans with product development.

The role requires strategic thinking, strong leadership, and up-to-date knowledge of evolving regulations, with a

Qualifications

• Bachelor's degree and 10+ years of experience in Regulatory Affairs for Class III implantable medical devices.
• Experience with FDA submissions and EU MDR technical documentation.
• Experience with combination product implantable medical devices.
• Strong leadership and team management skills.

Responsibilities

• 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.

Skills

Regulatory strategy

FDA submissions

Leadership

Global regulatory affairs

Regulatory intelligence

Cross‑functional collaboration

Negotiation

Education

Bachelor's degree in Regulatory Affairs

Job description

Biogen is seeking an Associate Director of Device Regulatory Affairs to lead regulatory strategies for Class III medical devices across the US, EU, and UK, directing major submissions and interactions with FDA and notified bodies. You will mentor a small global team and partner with Quality, Clinical, Engineering, and Manufacturing to align regulatory plans with product development.

The role requires strategic thinking, strong leadership, and up-to-date knowledge of evolving regulations, with a