Associate Director, Device Reg REQ24513

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. Your contributions will be vital in maintaining compliance and facilitating market access for innovative medical devices.

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.

Required Skills:

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.

Preferred Skills:

Advanced degree

Job Level: Management

Additional Information

The base compensation range for this role is: $160,000.00-$220,000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:

Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disab