Director of Regulatory Affairs
🕒 il y a 22 jours
🗣️🇺🇸🇬🇧 Anglais requis
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Description
• 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.
🎯 Exigences
• 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.
🏖️ Avantages
• Health insurance • Professional development opportunities
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