Regulatory Affairs Manager

As RA Manager, you will be responsible for new product submissions for regulatory approval in the US, Europe, Japan, China, Brazil, Australia, and more.

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 (Clinical Evaluation Report), PMS (Post Market Surveillance), and PMCF (Post Market

Clinical Follow-up) 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 -including experience with regulatory submissions

English - high level (both written and spoken).