RA/QA Manager (Temp) - Post-market Surveillance - Switzerland

RA/QA Manager Post- market Surveillance - Swiss MedTech - English essential
Our client is a Medical devices manufacturer based within reasonable commute of Zurich. They are undergoing strong growth partly also the result of acquisition, and will be looking for more staff across both Quality and Regulatory Affairs over the next few months - right now the position of greatest urgency is a experienced RA/QA Manager to prepare and manage all post market related activities.

This means to
- Manage Field Safety Corrective actions process and follow up
- Prepare all the responses for the Competent Authorities following FSCAs and Incident reporting worldwide.
- Manage all the responses to customers on post market related topics.
- Weekly update to top management on the open, in progress and completed responses to authorities.
- Complete all decision trees for reportability of events for all geographies.
- Support the update of Clinical Evaluation report
- Prepare and manage all post market surveillance documentation as per MDR (MDD 93/42)
- Represent PMS in all meetings related to new product development as well as on released products
- Support the preparation of Post market risk analysis
- Close all non-conformities and CAPA related to PMS activities
- Act as PMS SME in all internal and external audits

In order to fulfil these requirements, the candidate would typically have a Bachelor / MSc in a technical field and /or clinical background with several years experience managing post market activities (FSCA and vigilance) in a medical device company. They should have solid knowledge of product complaints processes in medical devices, a proven history in interacting with Competent Authorities, and strong knowledge of MDD 93/42 and MEDDEV 2.12-1.
The ability to work collaboratively in a matrix environment is essential, building local and global partnerships - towards that end English, both written and verbal, is required - German nice to have

This is a 6 month temp contract in the short term, but with big plans for the future, there is certainly possibility of extension. For more information on this vacancy, or any other QA opportunities within the DACH Medical Devices sector, please contact the Senior Consultant Andrew Boroky on 0041 43 50 80 816, or email him at quality@nonstop-devices.com together with scanned certifications of training and Arbeits Zeugnisse.

For industry news and new opportunities in QA within the Medical Devices and Diagnostics sectors, please join my Linked group at ch.linkedin.com/in/qaswitzerland/en

KEY WORDS: QMS, Quality Management System, Germany, Switzerland, Quality Assurance, Risk Management, Compliance, CAPA, Medical Devices, French, German, ISO 13485, ISO 9001, GMP, Medical Device jobs, Nonstop recruitment, Manufacturing, Engineering

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.