Senior Regulatory Affairs SpecialistMichael Page

Our client is a reference in the medical technology sector

• Directs the preparation and coordination of comprehensive regulatory submissions for Medical Devices, ensuring compliance with local and international regulations and achieving company objectives and timelines
• Leads the compilation of all materials required for regulatory submissions, renewals and annual registrations
• Represents the company's regulatory strategy with Notified Bodies and other Competent Authorities, builds and maintains positive relationships with them
• Provides expert guidance and advice to cross-functional teams on interpreting and communicating complex regulatory concepts and requirements
• Leads process improvement initiatives to streamline and optimize the regulatory process and procedures
• Contributes to the creation of regulatory strategy and plans to support the development and commercialization of new products
• 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
• Provides regulatory support to other departments such as R&D, engineering and clinical affairs as needed

• At least 8+ years of significant experience in regulatory affairs and quality compliance for medical devices according to EU regulation
• A Bachelors or Master's degree in engineering, medical technology or similar preferred
• In-depth knowledge of appropriate global medical device regulations, requirements, and standards, such as ISO 13485, European Medical Device Directive (93/42/EEC) and Regulation (2017/745/EU)
• Significant experience in design control, including new product development
• Knowledge of product EU regulations or directives (e.g. RED, ROHS, Waste Framework, …)
• Demonstrate organizational and planning skills, including action oriented, focus urgency and driving for results
• Demonstrate good interpersonal skills, ability to work with others in international team environment, effective interactions in cross department teams
• Ability to work autonomously, exercise daily judgment based on above regulatory knowledge
• Orientation for work result details, with emphasis on accuracy and completeness
• Fluent (C1 minimum) in written and spoken English