Regulatory Manager

Location: New York, USA Salary: competitive
Sector: Pharma & Biotech, Medical Devices, Regulatory Affairs, Regulatory Affairs (RA) Type: Contract

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.

Key Responsibilities:

  • 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!

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