Associate Director, Device Regulatory Affairs

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $160k - $220k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Biogen is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological diseases, including Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. With a strong emphasis on research and development, Biogen continues to advance the science of neurology through clinical trials and strategic partnerships, while also striving for access and health equity in healthcare.

📋 Description

• 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. • Manage a team of 2 global regulatory affairs staff. • Integrate regulatory requirements into product lifecycle planning and global commercialization strategies. • Serve as a senior regulatory representative in interactions with FDA, EU notified bodies, and UK approved bodies.

🎯 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. • 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

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