Remote Associate Director, Device Regulatory Affairs

Lifelancer; United States; Remote; USD 160,000 - 220,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

401(k) with company match

Tuition reimbursement up to $10,000/yr

Employee stock purchase plan

Paid vacation and holidays

Job summary

Biogen is seeking an Associate Director of Device Regulatory Affairs to lead regulatory strategies for Class III devices across the US, EU, and UK from a remote, USA-based role. You will manage a small team and serve as a senior regulatory lead in interactions with health authorities.

You will partner with Quality, Clinical, Medical Safety, Engineering, and Manufacturing to integrate regulatory requirements into lifecycle planning and worldwide commercialization efforts.

Qualifications

• Bachelor’s degree and 10+ years of Regulatory Affairs experience for Class III implantable medical devices.
• 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.

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 leadership

Regulatory strategy

Leadership

Cross-functional collaboration

Communication

Negotiation

Regulatory intelligence

Education

Bachelor's degree

Advanced degree

Job description

Biogen is seeking an Associate Director of Device Regulatory Affairs to lead regulatory strategies for Class III devices across the US, EU, and UK from a remote, USA-based role. You will manage a small team and serve as a senior regulatory lead in interactions with health authorities.

You will partner with Quality, Clinical, Medical Safety, Engineering, and Manufacturing to integrate regulatory requirements into lifecycle planning and worldwide commercialization efforts.