About This Role:As the Senior Manager of International Device Regulatory Affairs, you will lead regulatory strategies and execution for high-risk implantable medical device submissions beyond the United States, focusing on Japan, China, and Latin America. Your role encompasses developing and managing country-specific regulatory plans, submission content, and lifecycle maintenance activities to ensure timely market access and ongoing compliance.
Serving as the regulatory representative, you'll engage with international regulators, in-country representatives, and regional business partners, aligning strategically with their inquiries and requests. Collaborating cross-functionally with departments such as Quality, Clinical, Medical Safety, and global regulatory colleagues, you will integrate international regulatory requirements into product development and commercialization strategies. Your leadership will be instrumental in driving regulatory excellence and compliance, thereby contributing significantly to Biogen's international business objectives.
What You'll Do:- 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.
Who You Are: You possess a strategic mindset and a deep understanding of international regulatory frameworks, particularly for high-risk implantable medical devices. Your ability to navigate complex regulatory environments and engage effectively with international regulators is complemented by your collaborative spirit. With a keen eye for detail and a commitment to excellence, you thrive in cross-functional settings, driving compliance and innovation. Your leadership inspires others, and you approach challenges with resilience and adaptability.
Required Skills:- 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.
Job Level: Management
Additional InformationThe base compensation range for this role is: $138,000.00-$184,500.00
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
