Regulatory and Quality Assurance SpecialistMichael Page

Our client is a reference in the medical technology sector

• Support Regulatory Surveillance process with regards to local EU regulation(s); support RA intelligence and regulatory surveillance process
• Actively engage in process improvement initiatives to streamline and optimize the regulatory process and QMS procedures (commercial site and European region's management review)
• Support local team in documentation change control management and record management
• Partner with Change Control department to provide change control & documentation control guidance to the European sites
• Collaborate in the elaboration of in classroom training materials related to compliance topics (CAPA, audit readiness)
• Supports Quality Management system activities, such as CAPA, quality plans and audits
• Participates in internal/external audits and inspections, and ensures that company procedures, processes and documentation meet the requirements of the Quality Management System, ISO 13485 and other applicable regulations
• Supports process improvement and implementation of regulatory projects and tools

• Good Knowledge/understanding of the EU Medical Device Regulation (EU) 2017/745 and European Medical Device Directive 93/42/EEC, Swiss Medical Device Regulation (MedDO)
• Knowledge of Medical Device registration requirements in Europe and EUDAMED
• Knowledge of product EU regulations or directives (e.g. RED, ROHS, Swiss MedDO, …)
• General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
• 3-5 years of experience in a Medical Device Quality or regulatory compliance / Quality system department.
• A Bachelor's or Master's degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
• Experience in documentation control & record management (preferred)