Regulatory Specialist medical device

SCOPE & RESPONSIBILITIES

• Preparing, coordinating, tracking, and following up on submissions for medical devices in various international markets.
• Preparation and management of EU MDR technical ation 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 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)