Senior Manager, International Device Regulatory Affairs

Biogen

. Lead international regulatory strategy for high-risk implantable medical device programs, focusing on Japan, China, and Latin America .

Posted 9/15/2026full-timeRemote • United StatesSenior💰 $138,000 - $184,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in leading international regulatory strategies for high-risk implantable medical devices, with a strong focus on compliance and collaboration across global teams. Proven ability to mentor staff and manage complex regulatory submissions while ensuring adherence to evolving international regulations.

Highest-signal resume keywords

Regulatory Affairs ExperienceInternational Medical Device RegulationsCross-Functional CollaborationLeadership and MentorshipRegulatory Strategy Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentSubmission ManagementPost-Market SurveillanceDeficiency Response CoordinationRegulatory Intelligence Implementation

Soft Skills

Excellent CommunicationNegotiation Skills

Industry Keywords

Class III Implantable Medical DevicesCombination Product DevicesJapan RegulationsChina RegulationsLatin America Regulations

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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