Senior Manager of Regulatory Affairs

Title: Regulatory Affairs Senior Manager

Summary:

Our client is seeking an experienced Senior Manager of Regulatory Affairs to lead the preparation and submission of global regulatory filings, ensuring compliance with clinical, pre-, and post-market requirements. This role involves cross-functional collaboration, regulatory strategy development, and supporting post-market surveillance activities. It will also give you a create opportunity to contribute to the client's mission of developing innovative medical devices to treat cardiovascular disease.

The Senior Manager will be responsible for…

• Prepare high-quality regulatory submissions for investigational and commercial device applications.
• Provide regulatory strategy guidance for product development and quality system projects.
• Collaborate with internal teams and external regulatory bodies to ensure compliance.
• Support adverse event reporting, MDRs, vigilance reports, and post-market surveillance.
• Review technical documents, risk analyses, and change orders for regulatory impact.
• Assist in audits and maintain regulatory procedures.

The Senior Manager should have the following qualifications:

• Bachelor's degree in a scientific discipline (engineering, biology, etc.).
• 5-8 years of regulatory experience in medical devices, preferably Class III cardiovascular devices.
• Strong knowledge of global medical device regulations and quality systems.
• Experience with EU MDR implementation is a plus.
• Excellent technical writing, communication, and project management skills.