New · posted Nov 10
Biogen · Medical Devices
Associate Director, Device Regulatory Affairs
- Remote, US
- Remote
- Full-time
- Director
The 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 need
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.
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.
Preferred Skillsnice to have
- Advanced degree
Job Level: Management
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.
Pay and benefits
$160,000 – $220,000 a year
Employer providedAdditional 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 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
Medical, dental, vision and life insurance
401(k) with company match
Cash bonus and equity incentives
Employee stock purchase plan
Paid vacation, holidays and parental leave
Tuition reimbursement up to $10,000 per year
From the posting
About Biogen
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.
Equal opportunity, accessibility and legal noticesBiogen's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 24% below the US median for Regulatory Strategy roles at this level.
This roleEmployer provided
Director roles in the US45 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $160,000 | — | $220,000 |
| All US (middle half) | $227,500 | $250,500 | $272,500 |
This role: Biogen's own published range. Comparisons: the base pay employers published on open Regulatory Strategy roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Strategy
The general path across 90 open Regulatory Strategy roles on Regulatory Jobs, with the titles they carry most. Not Biogen's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Regulatory submissions8
- GMP and compliance4
- Documentation and SOPs1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Strategy work in medical devices, led by the two this posting names, each linked to the agency or standards body that publishes it.
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilanceNamed in the posting
- FDA21 CFR Part 4(official source, opens in a new tab)Current good manufacturing practice for combination productsNamed in the posting
- FDAFDA Q-Submission Program(official source, opens in a new tab)Pre-Submissions and meetings with FDA on device submissions
- FDAFDA De Novo(official source, opens in a new tab)Classification requests for novel low- to moderate-risk devices
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed device
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devices
- EUEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- FDAFDA eSTAR(official source, opens in a new tab)The electronic submission template for 510(k) and De Novo requests
- ISOISO 14155(official source, opens in a new tab)Good clinical practice for clinical investigations of medical devices
- FDAFDA cybersecurity in medical devices(official source, opens in a new tab)Quality system considerations and premarket content for device cybersecurity
Company hiring pulse
Biogen on Regulatory Jobs
- 23
- Open roles
- 23
- Distinct roles
- 4
- Locations
By discipline
- Clinical13 57%
- Quality6 26%
- Regulatory4 17%
By level
- Director8 35%
- Senior & Principal6 26%
- VP & Executive4 17%
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Associate Director, Device Regulatory Affairs at Biogen
Applications close November 14. $160K–$220K a year, employer provided.