RA Project Manager
RA Project Manager
09/01/2025We are seeking a skilled and detail-oriented RA Project Manager to join our team. This role is ideal for individuals passionate about regulatory affairs and making an impact in the medical device industry. SCOPE & RESPONSIBILITIES • Preparing, coordinating, tracking, and following up on submissions for medical devices in various international markets. • 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
• Degree in Biomedical Engineering or Biotechnology • 2-5 years of relevant previous experience in regulatory affairs of medical devices (preferred) • High-level proficiency in English (written and spoken). • Excellent teamwork ability and interpersonal skills. • Service oriented mindset with attention to details. • Ability to work in dynamic and multi-interfaced surroundings, micro and macro vision. • Strong attention to details. • Proficiency in Microsoft Office tools (Word, Excel, PowerPoint).