Manager Regulatory Affairs
Location: Northeast
Will provide regulatory strategy and FDA submission preparation support of technology
development programs involving medical devices, device/drug combinations, and gene
therapies.
Provide product approval strategies in support of Corporate technology development
projects.
Support the design of phase I, II, and III clinical trials.
Review for approval pre-clinical, including biocompatibility and clinical test protocols
and reports.
Prepare, submit, and gain approval of IDE applications to support clinical investigations.
Prepare or support the preparation of product approval applications (i.e. 510k, PMA).
Provide guidance to technology development teams on implementation of Quality Systems
Regulation, including design controls, requirements.
Bachelor's degree in a scientific or technical discipline; advanced degree preferred.
5-10 years regulatory affairs experience in the medical device industry; experience in
pharmaceuticals or biologics desirable.
Experience in the preparation of IDE, 510(k), PMA applications and review of pre-clinical
and clinical reports necessary.
Excellent verbal and written communication skills.
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