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Director of Regulatory Affairs
VIVEX BiologicsDirector of Regulatory Affairs managing biologics and medical device applications. Overseeing compliance and regulatory guidance for Vivex Biologics, Inc.
About the role
Key responsibilities & impact- Responsible for the coordination, compilation and submission of biologics and medical device applications.
- Develop and implement Chemical and Manufacturing Controls (CMC).
- Provide guidance to project teams on the regulatory framework from the FDA.
- Manage supplier and distributor qualifications and the company’s auditing program.
- Maintain voluntary accreditations, state licenses, and establishment registrations.
Requirements
What you’ll need- Bachelor of Science or Arts in a relevant discipline is required.
- Minimum of 7 years Tissue Bank, Medical Device, Biologics or Pharmaceutical experience with 4 years management experience preferred.
- AATB CTBS, ASQ, or other allied health licensure or certification preferred.
Benefits
Comp & perks- Health insurance
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Chemical and Manufacturing Controlsregulatory frameworkauditing programsupplier qualificationsdistributor qualifications
Soft Skills
coordinationguidancemanagement
Certifications
AATB CTBSASQ