Job Overview:
The Senior Manager of Regulatory Affairs plays a key leadership role in supporting regulatory activities for a portfolio of medical devices. This position entails implementing regulatory strategies, managing submissions, assessing the impact of product changes, and ensuring high-quality results through guidance and mentorship.
* In this capacity you will be responsible for developing and implementing global regulatory strategies throughout the product lifecycle from R&D to commercialization and post-market activities.
* You will collaborate with cross-functional teams to ensure regulatory requirements are incorporated into development plans and timelines providing guidance on submissions such as 510(k).
* This role requires overseeing preparation review submission of regulatory filings in the US EU liaison with regulatory bodies facilitating approvals resolving issues as needed