Regulatory Affairs Specialist
Peripheral and/or specialized implants are very challenging products and challenging products need talented regulatory people from design through to commercialization.
In a constantly changing landscape of Regulations, the most successful companies have a strong core of Regulatory Professionals and we are helping our client build onto theirs. Whether leading the strategy, or implementing it, whether for NPD or existing products, your contributions will impact the breadth of the product line. Your knowledge base in 13485, 14971, MDD/EU MDR and CMDCAS is, of course critical as you’ll be working with those guidance’s every day.
We are looking for 5 years’ experience at minimum working in an FDA regulated environment. Even with the required experience your analytical and technical writing skills are critical and we’ll look for you to demonstrate those. From review of engineering and marketing materials to labeling and including market release activities this role is not a pigeonhole but real opportunities to learn and grow.
- Supports the development and implementation of Regulatory Strategies for NPD projects
- Heavily involved with sustaining activities with the design and development teams such as FMEA’s, RMR’s, CN Review, and Labeling Review
- Works on cross-functional teams (NPD and Sustaining) as a Regulatory representative as well as supporting other Regulatory team members
- Contributes to responses to regulatory deficiencies; preparation, evaluation, and maintenance of domestic and international regulatory documentation
- Participates in Departmental audits and supports third party audits by BSI, FDA and others, as required
- Is a key team member in the regulatory review of Marketing and Engineering materials in NPD including labeling and market release activities
- BS/BA in a Scientific or Technical discipline with a minimum of 5 years’ experience and that must be in an FDA regulated environment
- Regulatory Affairs Certification is highly desired
- Working knowledge of 21CFR 820, ISO 13485 & 14971 with a working knowledge of MDD/EU MDR and CMDCAS highly valued
- Support of 510(k) writing and/or review experience preferred
- Orthopedic experience highly valued