Senior Regulatory CMC Lead for Devices & Combo Products

Regulatory Jobs; United States; Remote; USD 111,000 - 149,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Paid vacation and holidays

Tuition reimbursement

Employee stock purchase plan

Job summary

Biogen is seeking a Senior Regulatory CMC Device and Combination Product Lead to drive global regulatory strategies for medical devices and combination products. You will lead cross-functional teams, author submissions, and guide project work streams to ensure compliant, timely regulatory outcomes.

The role requires a BS with 5+ years in regulatory affairs, strong cross-functional collaboration, and knowledge of cGMP for devices.

Qualifications

• Bachelor’s degree and at least 5 years regulatory experience in medical devices/pharma/biotech.
• Experience coordinating regulatory submissions and authoring documentation.
• Strong understanding of how regulatory interfaces with multiple functions.

Responsibilities

• Represent Regulatory CMC device function on cross-functional teams.
• Author and coordinate regulatory documentation and submissions.
• Develop and execute regulatory strategies for medical devices and combination products.
• Monitor regulatory developments and communicate impacts to stakeholders.
• Lead regulatory intelligence activities and contribute to trade organization groups.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Regulatory communications

Regulatory intelligence

Education

Bachelor's degree (BS) in Life Sciences or Engineering

Job description

Biogen is seeking a Senior Regulatory CMC Device and Combination Product Lead to drive global regulatory strategies for medical devices and combination products. You will lead cross-functional teams, author submissions, and guide project work streams to ensure compliant, timely regulatory outcomes.

The role requires a BS with 5+ years in regulatory affairs, strong cross-functional collaboration, and knowledge of cGMP for devices.