Regulatory Affairs Manager

Title: Regulatory Affairs Manager

Summary: This includes developing and implementing regulatory strategies for product approvals, leading the registration of products, ensuring compliance with global regulatory requirements, and managing the regulatory affairs team. The role requires collaboration with product development, quality assurance, and other cross-functional teams to support the organization's goals.

The Regulatory Affairs Manager will be responsible for…

• Developing and implementing regulatory strategies to ensure timely approvals of new and existing products.
• Manage and maintain product registrations, licenses, and regulatory compliance globally.
• Serve as the primary contact with regulatory agencies, including the US FDA, Notified Bodies, and other international entities.
• Oversee the preparation of regulatory submissions, ensuring accuracy and compliance with all regulatory requirements.

Qualifications

• 5+ years of experience in the IVD regulatory medical device space
• Experience with EU IVD regulations