Senior Regulatory Affairs Specialist
- Entreprise
- Michael Page
- Date de publication
- 05.04.2024
- Référence
- 4593452
Description
Entreprise :
Our client is a reference in the medical technology sector
Description du poste :
- 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
Description du profil :
- 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