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

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 Regulatory Affairs Manager, New Product Development

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.

Requirements of the Regulatory Affairs Manager, New Product Development

• 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.

Responsibilities of the Regulatory Affairs Manager, New Product Development

The specific duties of the Regulatory Affairs Manager, New Product Development include but are not limited to:

• Serve as the regulatory representative on cross functional new product development teams (R&D, Quality, Clinical, Operations, Manufacturing, Marketing, Project Management).
• Provide early phase regulatory input to influence product design, technology selection, materials, intended use, and claims to ensure regulatory pathways remain feasible.
• Assess regulatory implications of proposed design concepts and usability requirements during early scoping and feasibility phases.
• Develop and maintain regulatory strategies for new products, including classification, market pathways, global submission requirements, and anticipated regulatory risks.
• Guide NPD teams in meeting regulatory expectations for design controls, including design input requirements, risk management, V&V planning, and labeling development.
• Ensure required regulatory documentation is incorporated into the Design History File (DHF), including risk analyses, human factors documentation, and clinical evidence plans.
• Review and approve design control deliverables pertinent to regulatory compliance.
• Conduct regulatory pathway assessments (e.g., 510(k), De Novo, PMA, EU Technical Documentation, global dossier requirements).
• Define evidence requirements needed for submissions (bench, biocompatibility, software, electrical safety, EMC, clinical, human factors, sterilization validation, packaging validation, etc.).
• Develop submission timelines aligned with NPD project milestones.
• Provide regulatory input on prototype testing and verification/validation test protocol acceptability.
• Partner with R&D, Clinical, and Quality to determine testing strategies that meet global regulatory expectations.
• Communicate regulatory requirements clearly to engineering and project teams, ensuring regulatory considerations are integrated into product requirements and technical specifications.
• Lead risk benefit discussions during development, ensuring alignment with global standards and regulatory expectations.
• Review and approve product claims, labeling, IFUs, marketing materials, and promotional concepts to ensure they align with intended regulatory pathways and evidence.
• Evaluate change impacts throughout development to maintain regulatory strategy alignment (design iterations, feature additions, material changes, etc.).
• Prepare regulatory submissions supporting new products (e.g., 510(k), De Novo, PMA modules, EU Technical Documentation, Health Canada license applications, etc.).
• Coordinate responses to regulatory authority questions during pre-submission consultations or formal submission reviews.
• Collaborate with Clinical Affairs teams to determine whether clinical evidence is needed based on intended use, claims, and market strategy.
• Advise on human factors study design, formative and summative usability testing, and documentation requirements to meet regulatory expectations.
• Monitor evolving regulatory requirements, standards, and guidance documents that impact new product development.
• Communicate relevant changes to the NPD team and update regulatory strategy as needed.
• Ensure regulatory considerations are addressed during transfer to manufacturing, including process validations, environmental controls, labeling systems, and packaging configurations.
• Review and confirm regulatory compliance of final product configuration prior to design freeze and commercial launch.

Location

111 West Oak Ave., Tampa, FL 33602

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Benefits/Compensation

This position is eligible for an annual bonus.

Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.

Salary Range

$113,903-$142,378 USD

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.