(Remote Work) Vice President, Regulatory Affairs – Axogen

Job Overview

• Job Title Vice President, Regulatory Affairs
• Hiring Organization Axogen
• Company Website https://www.axogeninc.com/
• Remote Locations US
• Job Type   Remote, Full-Time

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.

Job Responsibilities

• 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 This can include participation in working groups/committees with FDA and other international regulatory agencies.
• 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 outcome.
• 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, and,
• Develops and maintains current regulatory knowledge and ensure that staff is aware of new and existing relevant procedures, guidance, and regulations.

Job Requirements

• 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 the Center for Drug Evaluation and Research (CDER) of the FDA and/or the Center for Devices and Radiological Health (CDRH).

General activities and competencies will include:

• Competent presentation and written and verbal communications skills with team, peers, executive management, and/or board of directors.
• Demonstrate strong analytical thinking, organizational thinking skills.
• Ensure by example and via formal expectations the RA team provides actional feedback across all organizational levels, in support of mission objective achievement.
• Establish and manage the department budget cost-efficiently while always maintaining effectiveness.
• Develop, as necessary, company policies and procedures, and by example, compliance to company policies and procedures.
• Develop agreements and contracts in compliance with company procedure.
• Collaborate with diverse stakeholders and build strong, collaborative relationships; manage competing agendas and priorities across different functional departments.
• Set direction and focus through the planning and a regular performance review process and oversee staff development based on organizational objectives and performance management.
• Demonstrate cross-functional expertise in complex environments.
• Perform other related duties as assigned by supervisor.

Employee Benefits

How To Apply

Click “Apply” below to fill in the application form!