דרישות התפקיד וניסיון נדרש:
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 regulatory affairs 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).