ProClinical is currently seeking a Regulatory Affairs Manager, Implant Systems, for a world leading medical device company based in Switzerland. This medical device company is looking for a RA Manager who will provide the assessment, approval and regulatory implementation of change requests
- Training internally on relevant procedures and requirements
- Monitoring legislative environment in relevant markets
- Support SAP based reporting systems
- Development and execution of regulatory strategies for assigned development projects within the business unit
- Accountable for regulatory compliance
Skills and Requirements:
- 3 to 5 years' experience in regulatory affairs
- 2 to 5 years' Medical Device Experience
- Good knowledge of quality system requirements such as ISO 13485 and FDA's 21 CFR Part 820
- Knowledge of medical device legislation EU, US, AUS and CAN
- Strong interpersonal skills and proactive working attitude in a international matrix organization
- To be considered for this role, applicants must be either Swiss citizens, EU-nationals or have the legal right to live and work in Switzerland.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Valaince Penteng on +44 2038 4606 43 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.