Job Title: Regulatory Affairs Manager
The role of Senior Manager of Regulatory Affairs entails strategic planning and execution, collaborating closely with cross-functional partners to ensure regulatory needs are integrated into product development and lifecycle management.
This position requires a deep understanding of the global regulatory landscape and experience interacting with regulatory bodies. The successful candidate will be responsible for developing and implementing global regulatory strategies throughout the product lifecycle, from R&D through commercialization and post-market activities.
* Regulatory Strategy & Product Development: Provide guidance on product submissions (e.g., 510(k), etc.) while ensuring compliance with relevant regulations. Collaborate with cross-functional teams to integrate regulatory requirements into development plans and timelines.
* Market Access & Submissions:
* Risk Management & Compliance: