axogen · 4 hours ago
Regulatory Affairs Manager, New Product Development
Tampa, Florida, United States
Full-time
Onsite
Mid, Senior Level
4+ years expAxogen is committed to restoring health and improving quality of life through innovative medical products. The Regulatory Affairs Manager for New Product Development will lead regulatory efforts for new medical products, ensuring compliance with global standards and regulatory requirements throughout the product lifecycle.
BiotechnologyMedicalMedical Device
Responsibilities
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
Qualification
Required
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
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
Preferred
Prior experience in a regulated biologic, combination product, or device environment strongly preferred
Benefits
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
Disability Insurance
Company
axogen
AxoGen is a biotech company developing treatment options for the reconstruction and repair of peripheral nerve injuries.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$255.92MKey Investors
PDL Biopharma
2026-01-23Post Ipo Equity· $124M
2017-11-15Post Ipo Equity· $41M
2015-08-28Post Ipo Equity· $17.5M
Leadership Team
Michael Dale
President and Chief Executive Officer
Marc Began
Executive Vice President, General Counsel
Recent News
BioWorld Financial Watch
2026-01-25
legacy.thefly.com
2026-01-23
BioWorld Financial Watch
2026-01-23
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