California Licensed Regulatory Affairs Lead

A company is looking for a Regulatory Affairs Lead (Medical Devices).

Key Responsibilities :

Provide regulatory guidance and direction to cross-functional teams and company leadership

Develop strategies for new product development and modifications

Lead and coordinate regulatory submissions for US and EU markets

Required Qualifications, Training, and Education :

B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or Pharmacy preferred

Minimum 10 years of experience in the Medical Device industry, with 5+ years in regulatory affairs

In-depth understanding of US and EU Medical Device regulations

Extensive knowledge of design controls, risk management, and product labeling requirements

RAPS Regulatory Affairs Certification (RAC) is a plus