Regulatory Affairs Associate / Medical Device
- Kelly Services
- Suisse romande
- Date de publication
|Kelly Scientific is looking for a Regulatory Affairs Associate _ Medical Device for a great pharmaceutical company.|
• Preparation, submission and follow-up of technical files for the CE marking of class IIa, and class III medical devices.
• Preparation, submission and follow-up of changes to CE Technical Files including extensions to scope, raw material supplier and contract manufacturer.
• Maintenance of CE Technical Files including gap analysis of current processes against revised legislation and applicable harmonised standards to determine state of compliance, manufacturing methods and validation, biological safety evaluation and report compilation, clinical evaluation and risk analysis.
• Facilitate worldwide medical device registration activities by coordinating with distributors to compile appropriate dossiers, submissions and responses to regulatory bodies.
• Coordinate with sales and marketing colleagues to ensure the timely marketing authorisation of medical devices in new markets.
• Maintain information on worldwide regulatory requirements and the status of medical device registrations.
• Provide support and advice to company colleagues, concerning CE marking and other world regulatory requirements.
• Activities to enable the assembly of information for regulatory purposes as required.
- Diploma in Life Sciences degree
- 2 to 3 years’ experience of registering medical devices – class IIa, class III and preferably class III.
- Fluent in English
Mme DROMARD Mathilde, Consultant Professional Staffing Life Science and Deputy Manager
Rue du Rhône 114, 1204 Genève, Switzerland