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:
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).
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).
This position is open to all candidates.
