Associate Director, Device Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the global regulatory strategy for Class III medical device programs, which includes formulating integrated regulatory pathways and submission plans.

• Manage the preparation, review, and execution of significant regulatory submissions for Class III devices.

• Act as a senior regulatory lead for interactions with the FDA, EU notified bodies, UK approved bodies, and various global health authorities.

• Offer regulatory leadership for product development, design modifications, changes in manufacturing, labeling, clinical evidence, and risk management.

• Collaborate with cross-functional stakeholders to convert regulatory requirements into actionable program plans and submission-ready documents.

• Keep track of the evolving regulations, guidance, and standards for US and international devices, evaluating business implications and promoting the implementation of regulatory intelligence.

• Guide and mentor global regulatory staff and cross-functional teams, providing governance, issue escalation, and support for inspection/readiness.

• Lead a team of 2 global regulatory affairs personnel.

• Incorporate regulatory requirements into product lifecycle planning and global commercialization strategies.

• Represent senior regulatory interests in interactions with the FDA, EU notified bodies, and UK approved bodies.

⛳️ Requirements

• A Bachelor's degree and over 10 years of experience in Regulatory Affairs for Class III implantable medical devices.

• A minimum of 5 years of experience with combination product implantable medical devices.

• Proficiency with FDA submissions and EU MDR technical documentation.

• Knowledge of global commercialization strategies for medical devices.

• Strong leadership and team management capabilities.

• Exceptional communication and negotiation skills.

• Biogen is an E-Verify Employer in the United States.

🏝️ Benefits

• Medical, Dental, Vision, & Life insurances

• Fitness & Wellness programs including a fitness reimbursement

• Short- and Long-Term Disability insurance

• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)

• Up to 12 company paid holidays + 3 paid days off for Personal Significance

• 80 hours of sick time per calendar year

• Paid Maternity and Parental Leave benefit

• 401(k) program participation with company matched contributions

• Employee stock purchase plan

• Tuition reimbursement of up to $10,000 per calendar year

• Employee Resource Groups participation

• Short term and long-term incentives, including cash bonus and equity incentive opportunities