Kenilworth, MA -- A US-based Life Sciences company is currently seeking qualified candidates in the Kenilworth area to fill its Associate Director of Regulatory Affairs job opening.
Associate Director – Regulatory Affairs
Life Sciences Company
We
are representing a Life Science client that has doubled revenues over
the past five years. They operate on a global footprint and the
position is open due to an internal promotion.
Responsibilities of Associate Director of Regulatory Affairs:
- Responsible for providing Regulatory strategy for new product development.
- Provide
oversight in taking innovative ideas from proof of concept through
regulatory strategy, including product development, manufacturing,
filing and approval, and commercial operations.
- Responsible
for regulatory functions including planning and filing of documentation
with domestic and international regulatory agencies.
- Coordinates
the preparation of 510(k) Premarket Notifications, IDEs, PMAs, Design
Dossiers, Technical Files and other International Registrations.
- Prepares responses to FDA letters, supplements, and amendments; participates in FDA inspections and presentations as required.
- Writes
SOP’s and develops and implements training programs for direct reports
and other functional groups to assure awareness of all requirements and
maintain compliance with all current regulation.
Qualifications of Associate Director of Regulatory Affairs:
- Bachelor’s
degree with minimum 10 years of experience in preparing regulatory
submissions for device and/or drug, and biologic products.
- Must
have proven ability to prepare and submit documents to FDA, such as
510(k) Premarket Notifications, Investigational Device Exemptions
(IDEs), and Premarket Approval Applications, (PMAs), Investigational
New Drug (IND), or New Drug Applications (NDA).
- Must possess and demonstrate an excellent understanding of FDA and international regulatory requirements.
Submit resume to Maurice Gilbert at the following email address:
