Certification Specialist

Job summary
Looking for a CERTIFICATION SPECIALISTResponsible for regulatory activities related to documentation and certification of devicesCollaborating with the certification team and interacting with Notified Body
Job seniority: mid-to-senior level
Responsibilities
• Preparing technical documentation in compliance with EU Medical Devices Regulation• Collecting and reviewing technical documentation from the technical office or component suppliers• Preparing relevant technical documents (instructions, accompanying documentation, etc.)• Ensuring regulatory compliance of the Technical Dossier (maintaining active certifications and quality system)• Assisting in drafting test protocols in accordance with product standards (defining format, acceptance criteria)• Supporting CE marking activities and interacting with Notified Body• Coordinating with colleagues to create the documentation dossier• Managing product registrations in non-EU countries• Supporting firmware and software development activities (reviewing specifications for regulatory aspects, defining release methods)• Keeping up with regulatory and legislative updates
Requirements
• Technical diploma or preferably a degree in technical disciplines• Preferably experience in structured companies in the medical devices or pharmaceutical/mechanical sectors• Ability to cooperate with colleagues and work in a team• Good knowledge of English
Key Skills Needed
• Knowledge of EU Medical Devices Regulation• Technical documentation management• Understanding of product standards• CE marking• Firmware and software development• Regulatory and legislative compliance