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Senior Global Regulatory Affairs Leader (Medical Devices)

Werfen

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 #J-18808-Ljbffr Werfen

Vacancy posted 12 hours ago
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