Regulatory Affairs Manager

A company is looking for a Regulatory Affairs Manager.

Key Responsibilities :

Develops and implements regulatory strategies for medical devices and regulated products globally

Leads regulatory submissions, including 510(k) and CE marking technical files

Provides regulatory guidance to cross-functional teams and manages communications with regulatory agencies

Required Qualifications :

Bachelor's degree in life sciences, regulatory affairs, or a related discipline

5+ years of experience in regulatory affairs, preferably in the medical device industry

In-depth knowledge of FDA 510(k) and international regulations

Regulatory Certification (e.g., RAC) or a Master's degree in a scientific discipline is a plus

Experience with software as a medical device is a plus