Regulatory Affairs Specialist

A fast-growing medical device company focused on developing, manufacturing, and selling innovative devices for endovascular interventional procedures. As Regulatory Affairs Specialist, you will be responsible for new product submissions for regulatory approval in the US, Europe, Japan, China, Brazil, Australia, and more. If you thrive in a fast-moving, challenging atmosphere where every employee counts, you are invited to submit your resume. SCOPE & 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 quality assurance of medical devices (preferred) • English - high level (both written and spoken). • Excellent teamwork ability and interpersonal skills. • Service oriented. • Ability to work in dynamic and multi-interfaced surroundings, micro and macro vision. • Strong attention to details. • Computer skills (Microsoft Word, Excel, PowerPoint)