Sr. Regulatory Affairs Manager

Job Description:
The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions, including (k) and submissions. This individual will ensure compliance with all applicable regulations in the preparation of the submissions to FDA, provide regulatory guidance to cross-functional teams, and contribute to the successful approval and launch of innovative medical devices.

Responsibilities:

Prepare, review, and submit regulatory documents to FDA.

Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals.

Ensure that all products comply with applicable regulatory requirements, including FDA regulations and ISO standards.

Provide regulatory guidance to R&D team during product development life cycle.

Stay updated on changes in regulatory requirements and communicate potential impacts to the organization. <...