Regulatory Affairs Manager

A company is looking for a Regulatory Affairs Manager.

Key Responsibilities

Oversee the US and EU based Regulatory Affairs team and execute regulatory strategies for medical and non-medical devices

Lead regulatory submissions, including US 510(k)s and CE marking, and provide guidance on product lifecycle planning

Monitor global regulations and assist in the development of technical documentation for regulatory approval

Required Qualifications, Training, and Education

Bachelor's degree in a relevant field or equivalent experience

9 - 10 years of experience in a regulated industry, preferably with FDA and Software as a Medical Device

Strong knowledge of FDA Quality System Regulations and experience with regulatory filings

Experience with US FDA Class I and II medical devices, and familiarity with Class III devices is a plus

Knowledge of Medical Devices Regulations and related standards