I am partnering with a NY Based CRO to secure a Regulatory Affairs Manager on a Contract-to-Hire basis.
This role can be partly remote dependent on the individual but it is the preference of the hiring manager for there to be regular face-to-face interaction with the team.
The ideal candidate has at least 8 years of experience with Medical Device, IVD or Combination Product (preferred) regulatory submissions to the FDA and is either a Senior Regulatory Associate who is ready to move up to a Manager level position or someone already at the Manager level who is ready for a change. You should have an interest in device Regulatory Affairs.
- Lead regulatory teams with regard to regulatory issues and requirements.
- Contribute in the development of regulatory strategies for projects.
- Contribute to the writing and review of documents for regulatory submissions.
- Manage the assembly of regulatory filings: collecting relevant information, writing the application, directing Assistants/Coordinators on assembling components of the application, and reviewing complete application for accuracy and completeness following regulatory authority guidelines.
- Ensure timely regulatory submission.
- Work in resolving issues/inquiries/deficiency letters with regulators and follow-up to ensure initial applications are approvable.
- Manage and track submission timelines for Regulatory Affairs
- Maintain high level of knowledge of regulations, the regulatory process, and the application of regulations to assigned products and projects - expand regulatory background through work on projects, seeking guidance or advice from others when necessary, and attending relevant training.
- Act as a resource for support of Regulatory and client audit/reviews.
- Developing more Junior members of Regulatory Affairs team
- Managing coverage/redundancy in the Regulatory Team so that every role on the team has an experienced backup.
- Assign work for the team as projects arise
- Work closely with Associate Director to determine submission strategies, and to align Regulatory team goals and workflow with the company's vision.
If this is of interest, please apply now!
Sthree US is acting as an Employment Business in relation to this vacancy.