Vice President, Regulatory Affairs

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

Why you'll love working at Axogen:

• Friendly, open, and fun team culture that values unique perspectives
• Company-wide dedication to profoundly impacting patients' lives
• Comprehensive, high-quality benefits package effective on date of hire
• Educational assistance available for all employees
• Matching 401(k) retirement plan
• Flexible working hours
• Paid holidays, including floating holidays, to be used at your discretion
• Employee Stock Purchase Plan
• Referral incentive program

Job Summary of the VP, Regulatory Affairs

As a member of the Executive Team, the VP, RA will report directly to the Chief Executive Officer of Axogen. Consistent with Axogen's mission and business purpose, as a member of the Executive Team, the Vice President, Regulatory Affairs (VP, RA) is responsible for development and execution of the domestic and international regulatory strategies required for attainment of company objectives related to new product or therapy development, new product or therapy market approval, market development, and any other activity dependent on regulatory insight and leadership. As the leader of Axogen's regulatory affairs, the VP, RA is likewise responsible for maintenance of Axogen product registrations, licenses, accreditations and in general all related interactions and relationships with regulatory agencies and associated stakeholders. Additionally, the VP, RA will be responsible for working on development of regulatory policy with external groups such as Alliance for Regenerative Medicine (ARM), American Association of Tissue Banks (AATB) and others.

Requirements of the VP, Regulatory Affairs

• Bachelors' degree required; Masters' degree and/or Doctorate preferred.
• At least 15 years of progressive experience in a regenerative medicine, medical device, or pharmaceutical company with biologic experience a preferred capability.
• At least 5 years of experience in a leadership Regulatory Affairs position having direct reports.
• Professional experience and accomplishments will ideally include Biologics License Application (BLA) approvals and management. Alternatively, New Drug Application (NDA) or the Medical Device Class III level product or therapy approvals and management.
• Proven ability to develop relationships with the Center for Drug Evaluation and Research (CDER) of the FDA and/or the Center for Devices and Radiological Health (CDRH).

Responsibilities of the VP, Regulatory Affairs

The specific duties of the VP, Regulatory Affairs include but are not limited to:

• Acts as the "Authorized" Regulatory Affairs representative to external regulatory agencies and industry groups.
• Directs, controls, and implements regulatory activities in accordance with Axogen specifications, FDA, EU, and other relevant international authorities and regulations.
• Develops and manages regulatory strategy that contemplates and addresses when required the interdependencies between mission, objectives, strategy, structure, people, and process.
• Cultivates and maintains Axogen involvement in external groups such as Alliance for Regenerative Medicine (ARM) and American Association of Tissue Banks (AATB) to help shape regulatory policies.
• Prepares and/or oversees FDA and International submissions which could include, among others, IDEs, IND's, PMA's, 510(k)'s, Biologic License Applications (BLA), International Technical Files, Design Dossiers, product registrations, MDRs, Vigilance Reporting and Canadian reporting requirements and associated follow-up reports.
• Manages outside consultants when required.
• Participates, partners, and/or provides support for colleagues and product teams on regulatory matters.
• Leverages effective relationships with regulatory agency contacts to proactively facilitate optimal regulatory outcomes.
• Provides expert regulatory counsel on content and format, planning and managing regulatory activities throughout the product lifecycle.
• Analyzes and makes recommendations for improving regulations and guidelines.
• Communicates with US and international regulatory agencies.
• Develops and maintains current regulatory knowledge and ensures that staff is aware of new and existing relevant procedures, guidance, and regulations.

Location

111 West Oak Ave., Tampa, FL 33602

Benefits/Compensation

Axogen is on a hybrid work schedule for some of our positions based out of our headquarters in Florida, with 3 days in office and 2 days remote. The hybrid work schedule does not include sales or facilities in Ohio or Texas.

Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.