Global Regulatory Lead, Class III Medical Devices

Sigma Gamma Rho Sorority, Inc; Boston (MA); On-site; USD 160,000 - 220,000; Full time

Benefits offered by this job

Medical, Dental, Vision, Life ins.

401(k) company match

Employee stock purchase plan

Tuition reimbursement

Paid vacation & holidays

Parental leave

Job summary

Biogen is seeking an Associate Director of Device Regulatory Affairs in Boston, MA. You will lead regulatory strategy for Class III implants, manage global submissions, and partner with QA, Clinical, Medical Safety, Engineering, and Manufacturing to enable global market access.

You will mentor a small global regulatory team and act as the senior regulatory representative with FDA, EU notified bodies, and UK bodies, ensuring timely, compliant responses and inspection readiness.

Qualifications

• Bachelor's degree and 10+ years of 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.
• Global commercialization strategies for medical devices.
• Strong leadership and communication abilities.

Responsibilities

• Lead global regulatory strategy for Class III devices and develop submission plans.
• Direct preparation, review, and execution of major regulatory submissions.
• Represent regulatory leadership in interactions with FDA, EU bodies, and UK authorities.
• Provide governance on design changes, manufacturing changes, labeling, and risk management.
• Mentor global regulatory staff and cross-functional teams; support inspections.

Skills

Regulatory leadership

Regulatory strategy

Team management

Communication

Education

Bachelor's degree in a related field

Job description

Biogen is seeking an Associate Director of Device Regulatory Affairs in Boston, MA. You will lead regulatory strategy for Class III implants, manage global submissions, and partner with QA, Clinical, Medical Safety, Engineering, and Manufacturing to enable global market access.

You will mentor a small global regulatory team and act as the senior regulatory representative with FDA, EU notified bodies, and UK bodies, ensuring timely, compliant responses and inspection readiness.