Our client is a medical device company, based in Neuchâtel.
Your main mission will be to develop, support and improve Quality, Regulatory and Clinical processes, in order to meet applicable medical device standards and regulations.
You will be in charge of :
- Regulatory survey, Document control, review and approval of labelling and marketing material, Change control management
- Customer complaint handling, Post Market Surveillance and Vigilance reporting
- Support with Internal audits and Notified Body audits, including handling corrective and preventive actions
- Act as the primary contact for product registration and regulatory affairs with sales team and distributors.
- Prepare documentation for products registration and change notifications in defined countries, and ensure follow-up
- Prepare and update Summary Technical Documents (STED) for all products
- Follow-up of post-market clinical studies (PMCF): preparation of documentation and submission to ethical committee.
Your Profile :
- Ideally 3 years’ experience in Regulatory Affairs and/or Quality Assurance in medical device industry required
- Knowledge of the Medical Device Regulation MDR 2017/745 and ISO13485 standard.
- Accuracy and willing to work with high level of details
- Good capabilities and communication skills
- Fluent in English good level of verbal and written
- French and other languages are a plus