Innovative Tissue Based Therapies
Director of Regulatory Affairs
Location
United States
Posted
18 days ago
Salary
0
Seniority
Lead
Job Description
Director of Regulatory Affairs
VIVEX Biologics
• 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.
Job Requirements
- 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
- Health insurance
- Professional development opportunities
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