Regulatory Affairs Manager
This position is a key member of the Aziyo Biologics team and as such is involved in setting the Company’s long-term vision and short- term goals and objectives.
The Regulatory Affairs Manager works directly with the Food and Drug Administration (FDA), and other domestic and international regulatory agencies, and internal personnel to obtain and maintain product approvals and maintain regulatory compliance.
This position reports to EVP, Regulatory & Scientific Affairs
Essential Duties & Responsibilities
• Contribute to and develop regulatory strategies for product approval by both domestic and foreign agencies.
• Prepare timely and compliant submissions to domestic and international regulatory agencies (510(k), IDE, PMA, HDE, IND, BLA, CE dossiers, supplements, responses, state licensure/certifications, export certifications, product registrations, etc.).
• Identify, collect, review and evaluate information critical to submission packages.
• Interpret regulations and related information for Research & Development, Operations, Quality Assurance, and Marketing.
• Evaluate and recommend changes to labeling, marketing literature, and clinical protocols for regulatory compliance to recognized laws or regulations.
• Contact FDA and other government agencies as needed and assist in facility inspections from local, state, federal, and international agencies.
• Responsible for the identification of issues and initiation of actions to prevent the occurrence of any nonconformity relating to products, processes, and the quality system as applicable to the responsibilities outlined with this job description.
Bachelor’s degree in a scientific discipline from an accredited college or university
Experience and Skills
Work Experience Required:
• Minimum of 5 years’ experience in medical device Regulatory Affairs
Specialized Skills, Knowledge:
• None Required
• RAC certification preferred