Summary

As the Associate Director of Device Regulatory Affairs, you will be at the forefront of leading regulatory strategies and execution for Class III medical device submissions across the United States, European Union, and United Kingdom. You will manage a team of 2 global regulatory affairs staff, ensuring that all regulatory plans, submission content, and approval strategies are meticulously developed and aligned with high-risk device programs. Your role is pivotal in serving as a senior regulatory representative in interactions with key health authorities, including FDA, EU notified bodies, and UK approved bodies, to ensure timely and compliant responses. Collaborating cross-functionally with teams such as Quality, Clinical, Medical Safety, Engineering, and Manufacturing, you will integrate regulatory requirements into product lifecycle planning and global commercialization strategies.

Job description

About This Role

As the Associate Director of Device Regulatory Affairs, you will be at the forefront of leading regulatory strategies and execution for Class III medical device submissions across the United States, European Union, and United Kingdom. You will manage a team of 2 global regulatory affairs staff, ensuring that all regulatory plans, submission content, and approval strategies are meticulously developed and aligned with high-risk device programs. Your role is pivotal in serving as a senior regulatory representative in interactions with key health authorities, including FDA, EU notified bodies, and UK approved bodies, to ensure timely and compliant responses. Collaborating cross-functionally with teams such as Quality, Clinical, Medical Safety, Engineering, and Manufacturing, you will integrate regulatory requirements into product lifecycle planning and global commercialization strategies.

What You'll Do

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.

Who You Are

You are a strategic thinker with a deep understanding of regulatory affairs for Class III medical devices. Your attention to detail and ability to navigate complex regulations allows you to effectively lead and mentor teams. You thrive in a collaborative environment, valuing cross-functional partnerships to achieve business goals. Your proactive approach and dedication to compliance ensure that you stay ahead of evolving regulatory landscapes, driving successful submissions and approvals.

Requirements

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
Advanced degree preferred

Benefits

Medical, Dental & Vision
Life Insurance
Fitness & Wellness Programs
Short- & Long-Term Disability
15 Days Paid Vacation
End-of-Year Shutdown
12 Paid Holidays
80 Hours Sick Time
Paid Maternity & Parental Leave
401(k) Matching
Employee Stock Purchase Plan
Tuition Reimbursement
Employee Resource Groups

Company overview

Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.