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-LjbffrVacancy posted 5 days ago
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