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:Job Level: Management
Additional InformationThe 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 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
Why Biogen?We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
