- Author, review, and track submissions and other regulatory documents to obtain approval to bring new or modified products to market.
- Interact and communicate with regulatory health authorities through oral and written communications regarding pre-submissions strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
- Interface and coordinate with FDA and other regulatory agencies on submissions, approvals or other issues.
- Support marketing, new product development and operations in regulatory assessment of proposed changes. Perform and document regulatory assessments for modifications to existing devices.
- Interpret existing and/or new regulatory requirements as they relate to company products and procedures. Communicate this to appropriate personnel.
- Prepare and update US product listings and establishment registration.
- Prepare and maintain international product registrations.
- Monitor activities/publications of FDA and international regulatory bodies to identify and respond to new or revised regulatory requirements.
- Represent Regulatory Affairs during FDA inspections or other government agency audits as required.
- Improve the regulatory aspects of the Quality System, developing processes and documenting procedures to maintain an effective quality system.
- Background in statistics, quality inspection methods, and inspection methods
- Analyze QMS metrics and develop recommendations for improvement to the Management Team.
- Completes other tasks as assigned by supervisor.
- Bachelor’s Degree in a technical or scientific field
- Minimum 3 years of experience in medical device regulatory affairs
- Ability to interpret regulatory requirements and communicate them to technical functions within the company
- Must have experience with successful preparation and submission of Technical File, Design Dossiers, 510(k), and international documents or registration of medical device worldwide.
- Knowledgeable of MDD and MDR, ISO13485, IDE and 510(k) premarket notification.
- Working knowledge of medical device regulations (21CFR), FDA law and CE marking
Experience in supporting international registrations.
Founded in 2014, Neoteryx is a medical device company shaping the future of healthcare. Our breakthrough blood collection technology – VAMS™ – is used by pharmaceutical giants, organ transplant patients, researchers in economically disadvantaged regions, and others on the leading edge of science and medicine. When you join our fun, tight-knit team, you’ll discover what one drop of blood can do, and be part of microsampling innovations that will change the world.