Regulatory Affairs Project Manager

A fast-growing medical device company focused on developing, manufacturing, and selling innovative devices for endovascular interventional procedures is seeking a talented RA Project Manager!

RESPONSIBILITIES :

• Preparing, coordinating, tracking, and following up on approvals for medical device submissions in the US (510k, Denovo), Japan, China, Brazil, Australia, and more.

• Preparation and management of EU MDR technical documentation submissions.

• Oversees CER, PMS, and PMCF activities, including customer complaints, vigilance, and recall.

• Participate in regulatory inspections and audits.

• Prepare regulatory assessments for design changes.

• Developing labeling according to applicable regulatory requirements.

REQUIREMENTS 

• Degree in Biomedical Engineering / Biotechnology

• 2-5 years of relevant previous experience in regulatory affairs of medical devices (preferred)

• English - high level (both written and spoken).