Regulatory Affairs Manager, Product Development

Overview

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.

• 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

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.

The Regulatory Affairs Manager for New Product Development (NPD) serves as the primary regulatory lead for early‑stage and full‑lifecycle development of new medical products. This role partners closely with cross‑functional teams—including R&D, Quality, Clinical, Project Management, Operations, Manufacturing, and Marketing—to ensure that regulatory requirements, global standards, and compliance considerations are fully integrated into product design and development from concept through commercialization.

The manager is responsible for developing regulatory strategies, identifying global regulatory pathways, and defining the evidence and testing requirements needed to support new product submissions. This role provides proactive guidance on design controls, risk management, verification and validation plans, labeling, and clinical or human factors needs. The Regulatory Affairs Manager ensures that all regulatory deliverables are completed according to project timelines and that the Design History File (DHF) fully reflects regulatory compliance throughout the development process.

Acting as the primary interface with regulatory authorities during the development of new products, the Regulatory Affairs Manager prepares and leads regulatory submissions (such as 510(k), De Novo, PMA modules, or global dossiers) and coordinates regulatory meetings and communications. This role is essential in supporting innovation while ensuring new products meet all applicable regulatory expectations, aligning product claims and design decisions with feasible approval pathways, and enabling successful product launches in targeted markets.

• Minimum 4 years of experience in Regulatory Affairs, with at least 2 year focused on new product development programs.
• Demonstrated leadership experience (cross-functional team leadership).
• Experience in regulatory writing and submitting successful regulatory submissions in both domestic and international markets
• Prior experience in a regulated biologic, combination product, or device environment strongly preferred.
• Strong project management and strategic problem-solving skills; ability to manage multiple priorities in a fast-paced environment.
• Comprehensive knowledge relating to 21 CFR 210, 211, 312, 314, 600, 601, Current Good Clinical Practices (cGCPs), and ICH efficacy and safety guidelines.

The specific duties of the Regulatory…