Sr. Regulatory Affairs Specialist
El Paso, TX
- The Sr. Regulatory Affairs Specialist will translate regulatory requirements into project/product requirements, prepare worldwide regulatory submissions, and negotiate their approval. In addition this professional will support pre/post-market compliance activities including product change notifications, and evaluating changes for regulatory impact. The Sr. Regulatory Affairs Specialist will possess Class I, II, III medical device experience and in-depth knowledge of FDA medical device regulations.
- A track record of developing and executing strategies for global regulatory approval.
- 5+ years medical device industry experience with a minimum of 3 years regulatory role. Or advanced degree with 4-5 years industry experience.
- Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), EU Medical Devices Regulation (MDR 2017/745), and ISO 13485.
- Class I, II, III medical device experience and in-depth knowledge of FDA medical device regulations.
- Proven ability to maintain Regulatory Affairs product files and ensure compliance with regulatory requirements.
- Combination product, tissues of animal origin, and/or pharmaceutical experience.
- Vascular access product experience.
- Proven ability to negotiate with regulatory authorities to resolve questions/issues that arise during submission review.
- Willingness participate on audit and field action teams as required.