Regulatory Manager, US Submissions (Medical Device)
|Job Id: 20141|
|Job Type: Permanent|
|Industry: MEDICAL DEVICES|
|Worksite Location: Headquarters office|
|Location: Frisco, TX 75034|
Join this globally recognized medical specialty product manufacturer. Their commitment to quality is reflected in their products, as well as their people...
Want to be the next great hire on this team? They’re looking to add a US Regulatory Affairs Manager to their Regulatory and Quality team.
ABOUT THE ROLE:
As the Regulatory Affairs Manager, you will manage and develop strategies for US/FDA governmental approvals, while introducing new medical products to market, providing advice on regulatory requirements, supporting the development of worldwide submissions, and facilitating their approvals. The Regulatory Affairs Manager will also manage any regulatory issues related to development, manufacturing, and commercialization and recommend solutions.
THE IDEAL CANDIDATE HAS…
- Bachelor's degree in science, math, or related engineering discipline
- RAPS certification: (RAC or RAC-US)
- 10+ of work experience with U.S. Regulatory Submissions, including experience as a regulatory team member on New Product Development Teams, having participated on at least ten (10) FDA 510(k) submissions, with submission lead experience for at least three (3) submissions; OR, experience as a regulatory team member for three (3) FDA PMA submissions.
- IDE support, review, and defense experience
- Prior experience interfacing with the FDA during inspections and technical presentations
- Experience in pre-submission/Q-Sub meetings with FDA preferred
- IEC 60601 and eQMS experience preferred
WHAT YOU’LL RECEIVE:
- Attractive salary + bonus
- Rich, competitive benefits package
- A great company culture + the latest technologies