Sr. Regulatory Affairs Specialist

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 
• Paid holidays, including floating holidays, to be used at your discretion 
• Employee Stock Purchase Plan 
• Referral incentive program 

If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories: https://www.axogeninc.com/patient-stories/ 

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Sr. Regulatory Affairs Specialist 

• Reporting to the VP, Regulatory, a core focus of the Sr. Regulatory Affairs Specialist is to author high-quality regulatory documents, including Chemistry, Manufacturing, and Controls (CMC) summaries, clinical summaries, and other sections of the Electronic Common Technical Document (eCTD) required to support Axogen’s regulatory dossiers.
• With appropriate guidance from the RA leads and internal technical SMEs, the RS will prepare, compile, and present data consistent with regulatory requirements. Verifies quality, completeness, and accuracy of information. Acts as an interdepartmental liaison when necessary to ensure all regulatory document deliverables are processed and compiled in alignment with timelines.
• As a member of the Regulatory Team, the RS is responsible for understanding, compiling, and maintaining regulatory information/databases or systems, including creating and maintaining Biologics, Device, and Tissue Product and Combination Product Dossiers and related reports including the generation of and/or assessment of product compliance reports.
• Develops or conducts employee regulatory training.
• Assists in regulatory and compliance inspections.
• Reviews change controls, deviations and other quality records for impact to regulatory status of commercial products.
• Collaborates maintaining Risk Management files and quality system processes, such as design controls, change control, labeling, advertising, etc.

Requirements of the Sr. Regulatory Affairs Specialist 

• Bachelor’s degree in Life Sciences, Engineering or English preferred, or in a related field commensurate with experience
• 3+ years of experience authoring and working with Biologics, Pharmaceutical, Device or Tissue regulatory submissions
• Knowledge of Biologics, Pharmaceutical and Device or Tissue regulations and Quality System regulation requirements (e.g., 21 CFR Part 820, 21 CFR Part 1271, 21 CFR Part 210/211, 21 CFR Part 600, ISO 13485, ISO 9001, ISO 14971, AATB accreditation guidelines)
• Knowledge of ICH’s eCTD/eCTD EU specifications
• Demonstrated ability to effectively communicate both verbally and in writing
• Successful history of handling multiple tasks, prioritizing activities, and scheduling work to meet business needs
• RAPS Regulatory Affairs Certification (RAC) preferred
• Ability to be flexible with changing priorities
• Experience with application of risk management processes
• Ability to travel approximately 20%

Responsibilities of the Sr. Regulatory Affairs Specialist 

The specific duties of the Sr. Regulatory Affairs Specialist  include, but are not limited to:

• Prepare, author, edit, compile, and review high-quality, clearly messaged documents in compliance with regulatory standards for submission to regulatory agencies and health au