Regulatory Affairs Manager, New Product Development

Axogen•Tampa, FL

12h•Onsite

About The Position

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

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

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.