The Director of Regulatory Affairs (RA) is responsible for the oversight of the company’s industry-specific practices and ensuring Medical Device, human tissue, Health Care Compliance, and other government, financial and corporate regulations and standards are being met. This Director of RA will be a key member of the Aziyo Biologics team and will lead and execute the Regulatory-related aspects of the Company’s long-term vision and short- term goals and objectives.
The Director of RA will be responsible for the company’s external relationships the Food and Drug Administration (FDA) and other domestic and international regulatory agencies, as well as internal leadership for personnel to obtain and maintain product approvals and maintain regulatory compliance.
This position reports to Chief Medical Officer
Essential Duties & Responsibilities
Lead development and execution of regulatory strategies for product approval and life cycle management by both domestic and foreign agencies.
Leads, coordinates and manages 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 Product Development, Clinical data protocols, Operations, Quality Assurance, and Marketing.
Establishes positive working relationships with relevant FDA professionals that review or evaluate Aziyo submissions.
Provides updates on strategic regulatory intelligence, such as new regulations, guidance, competitive product applications and approvals, etc.
Provides regulatory intelligence to inform regulatory strategies, including scenarios for the earliest regulatory approvals possible as well as an assessment of risk for each of the various scenarios.
Evaluate and recommend changes to labeling, marketing literature, and clinical protocols for regulatory compliance to recognized laws or regulations.
Participates in relevant industry working groups, such as RAPS, etc.
Contact FDA and other government agencies as needed and assist in facility inspections from local, state, federal, and international agencies.
Experience and Skills
Work Experience Required:
Minimum of 5 years’ experience in medical device Regulatory Affairs and knowledge of regulatory requirements
Specialized Skills, Knowledge:
Excellent written and oral communication skills
Strong time and project management skills.
Takes ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary
Proficient at critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
Knowledgeable in industry trends for study reports and dossier preparation
Proficient in pertinent software & tools
RAC certification preferred
Telecommuting is allowed.
Internal Number: 1001
About Aziyo Biologics, Inc.
Aziyo Biologics is a fully integrated, commercially oriented regenerative medicine company. Since its founding in 2015 the company has expanded through acquisitions and strategic partnerships, creating a high growth commercial entity. Its proprietary products are used in orthopedic, cardiovascular, and other medical specialties.