Director of Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the coordination, compilation, and submission of applications for biologics and medical devices.

• Create and execute Chemical and Manufacturing Controls (CMC).

• Offer guidance to project teams regarding the regulatory framework established by the FDA.

• Administer supplier and distributor qualifications along with the company’s auditing program.

• Ensure maintenance of voluntary accreditations, state licenses, and establishment registrations.

⛳️ Requirements

• A Bachelor of Science or Arts degree in a pertinent discipline is mandatory.

• At least 7 years of experience in Tissue Banks, Medical Devices, Biologics, or Pharmaceuticals, with a preference for 4 years in a management role.

• Preferred licensure or certification includes AATB CTBS, ASQ, or other allied health credentials.

🏝️ Benefits

• Health insurance

• Professional development opportunities