Senior Manager, International Device Regulatory Affairs

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $138k - $184.5k / 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 international regulatory strategy for high-risk implantable medical device programs, focusing on Japan, China, and Latin America • Serve as the regulatory lead for interactions with international regulators and certification bodies • Provide regulatory leadership for product development, design changes, and post-market surveillance • Collaborate with cross-functional teams to translate country-specific requirements into actionable program plans • Monitor and assess evolving international medical device regulations and drive implementation of regulatory intelligence • Mentor regulatory staff and cross-functional teams, supporting inspection readiness and leadership communication • Manage coordination of ex-US submission and deficiency response activities • Ensure compliance with international medical device marketing regulations • Represent Device Regulatory Affairs in routine health authority interactions

🎯 Requirements

• Bachelor’s degree; advanced degree preferred • 7+ years of Regulatory Affairs experience in Class III implantable medical devices • At least 5 years of experience with combination product implantable medical devices • Strong understanding of international medical device regulations, especially in Japan, China, and Latin America • Experience with cross-functional collaboration in a global setting • Proficiency in managing regulatory strategies and submissions for complex medical devices • Proven leadership and mentorship capabilities • Excellent communication and negotiation skills

🏖️ Benefits

• Regular employees are eligible for short-term and long-term incentives, including cash bonus and equity incentive opportunities • 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 • 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