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REGULATORY - Medical Device 510k experience

Posted 2 years ago in Biotech/Pharmaceutical



Boston, MA area client

Client has a 510k application that requires tactical submission support. PROJECT DETAILS:
Our client needs 510k submission support for a component valve used to build stents. The consultant would support a regulatory/quality team to interface with other functional groups and put together the submission package.
REQUIREMENTS:
Consultant should have 510k experience at the senior regulatory specialist level (medical device).
SCOPE:
On-site, 3 months (could go to 6), full-time.

About BioBridges, LLC:

BioBridges provides critical resources and consulting expertise to help emerging pharmaceutical, biotechnology and medical device companies successfully outsource their clinical trials. We also offer flexible solutions to help CROs satisfy their ever-changing business demands.
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