Regulatory Affairs Specialist (Remote)
Are you a regulatory affairs specialist with expertise in in vitro diagnostic products? Do you have experience with ISO 13485, 21 CFR 820, 510(k) submissions, and ISO 14971 risk management? We have an exciting opportunity for you to join our team as a regulatory affairs specialist.
In this role, you will be responsible for ensuring that our in vitro diagnostic products are compliant with all relevant regulatory requirements. You will work closely with cross-functional teams to prepare and submit 510(k) applications to the FDA and manage the regulatory approval process. You will also be responsible for maintaining regulatory compliance throughout the product lifecycle, including implementing and maintaining an ISO 13485 quality management system.
If you have a strong understanding of regulatory requirements for in vitro diagnostic products and are looking to take your career to the next level, we encourage you to apply for this position. This is a unique opportunity to work with a talented team and make a real impact on the quality and safety of our products.
Key Duties and Requirements
- Works cross-functionally to ensure risk and compliance standards are clearly defined and mitigated.
- Ensures that national and international medical device and ISO compliance regulations for the design and development of medical devices are met, including FDA's Quality System Regulation (21 CFR Part 820), ISO 13485, European or In Vitro Diagnostic Medical Device Directive, and others.
- A minimum of 1 year of direct ISO 14971 Risk Management experience is required, including preparation of Risk Management Plans, Hazard Assessments, Usability Engineering, Human Factors Analysis, etc.
- Experience supporting premarket regulatory submissions (e.g., 510(k)s and/or PMAs) is strongly preferred; preference given to candidates with experience in risk analysis
- Create and maintain Risk Management Files for in vitro diagnostic medical devices for new product introductions and existing project modifications.
Please don't hesitate to reach out and apply! If you know of anyone in your network who could be a good fit - please share!