Senior Regulatory Specialist - Alameda

Only for registered members Alameda, United States

1 week ago

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$140,000 - $185,000 (USD)

Job summary

We are seeking a Senior Regulatory Specialist to join our Quality and Regulatory Affairs team. This role will drive global regulatory strategies for our medical device and biologic products.


Responsibilities

  • Develop and execute strategic regulatory plans for medical devices and combination products development programs across multiple global markets.
  • Lead, prepare, author, and coordinate regulatory submissions including IDEs, 510(k)s , PMAs , technical files for CE marking ,and other international registrations .

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