Global Device Regulatory Lead (Class III)

Biogen, Inc.; United States; Remote; USD 160,000 - 220,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life insurance

Wellness programs

Job summary

Biogen, Inc. is seeking an Associate Director of Device Regulatory Affairs to lead global regulatory strategy for Class III devices across the US, EU, and UK.

You will manage a small team, guide submission plans, and interact with FDA and global notified bodies to ensure timely, compliant approvals. You will collaborate with Quality, Clinical, Medical Safety, Engineering, and Manufacturing to integrate regulatory requirements into lifecycle planning and commercialization strategies, while

Qualifications

• Bachelor’s degree required with 10+ years in Regulatory Affairs for Class III implantable devices.
• Experience with FDA submissions and EU MDR technical documentation.
• Strong leadership, communication, and cross-functional collaboration skills.

Responsibilities

• Lead global regulatory strategy for Class III medical device programs and submission plans.
• Direct preparation, review, and execution of major regulatory submissions for Class III devices.
• Serve as senior regulatory lead in interactions with FDA, EU notified bodies, and UK bodies.

Skills

Global regulatory strategy

Regulatory submissions

Leadership / team management

Regulatory intelligence monitoring

Regulatory interactions with health-​​

Education

Bachelor’s degree

Job description

Biogen, Inc. is seeking an Associate Director of Device Regulatory Affairs to lead global regulatory strategy for Class III devices across the US, EU, and UK.

You will manage a small team, guide submission plans, and interact with FDA and global notified bodies to ensure timely, compliant approvals. You will collaborate with Quality, Clinical, Medical Safety, Engineering, and Manufacturing to integrate regulatory requirements into lifecycle planning and commercialization strategies, while