Senior Global Regulatory Affairs Leader; Medical Devices
Listed on 2026-10-12
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Healthcare
Healthcare Compliance, Medical Science Liaison
Werfen in Bedford, MA seeks a Regulatory Affairs professional to lead pre-market activities for FDA, Health Canada and EU submissions, ensuring labeling and registrations meet global requirements. You will collaborate with R&D and Marketing to prepare FDA 510(k), HC licenses, and EU Notified Body submissions, guiding projects through regulatory pathways for successful launches.
Candidates bring at least 8 years of medical device regulation experience with strong written and verbal communication
For the Senior Global Regulatory Affairs Leader (Medical Devices) position at Werfen, we are reviewing applications now.
We are looking to fill the Senior Global Regulatory Affairs Leader (Medical Devices) position at Werfen in Bedford, MA, United States.
The Senior Global Regulatory Affairs Leader (Medical Devices) role at Werfen is now open for applications in Bedford, MA, United States.
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