biogen
The Associate Director of Device Regulatory Affairs leads regulatory strategies and execution for Class III medical device submissions across the United States, European Union, and United Kingdom. This role involves managing a global regulatory affairs team, serving as a senior regulatory representative in interactions with key health authorities, and collaborating cross-functionally to integrate regulatory requirements into product lifecycle planning. The position is pivotal in maintaining compliance and facilitating market access for innovative medical devices.
Headquarters
Cambridge, Massachusetts, United States
Company Size
5001-10000 employees
Founded
1978
Biogen is a leading biotechnology company that pioneers innovative science to develop new medicines aimed at transforming patients’ lives while creating value for shareholders and communities. It applies a deep understanding of human biology and leverages multiple modalities to advance first-in-class therapies that deliver superior clinical outcomes. Biogen balances bold scientific risk-taking with return-on-investment discipline to drive long-term growth.
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
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16% below the average for this role