REGULATORY - Medical Device 510k experience

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.