QA/Vigilance Manager - post market reporting essential- English

QA/Vigilance Manager - post market reporting experience essential- English - Swiss MedTech - 6 month duration, but with good chance of extension

Today I am looking for a QA/Vigilance manager within a Medical Devices company located just outside of Zurich, to take responsibility for preparation and management of all post market related activities. This is a key role within the organisation to drive and improve the complaints handling and vigilance reporting processes and ensure complaints are prioritised, investigated, and resolved in a timely fashion. It is also aimed at compliance to the MDR and developing/upgrading the QMS.

This is a FIXED term 6 month position in the first place - this is more a matter of process and there is a good history of similar positions becoming permanent before the 6 month period is complete.

Key Responsibilities:

• Immediate management of Field Safety Corrective actions and follow up
• Communication with Competent Authorities for incident reporting worldwide
• Acting as PMS SME in all internal and external audits
• Advice on new product development
• Preparation and management of all post market surveillance documentation as required by the MDR.

Key Requirements:

- Bachelor / MSc in technical field and /or clinical background.
- Several years experience managing post market activities (FSCA and vigilance) in a medical device company.
- Proven experience in interacting with the Competent Authorities all over the world.
- Strong knowledge of MDD 93/42 and regulations WW.
- Knowledge of product complaints processes within the medical devices industry

- Fluency in English both written and verbal is essential

For more information on this vacancy, please contact the Senior Consultant Andrew Boroky on 0041 43 50 80 816, and email him your resume in WORD format to quality@nonstop-devices.com. For industry news and new opportunities in QA within the Medical Devices sectors, please join my Linked group at ch.linkedin.com/in/qaswitzerland/en

Keywords: Returned Devices Adverse Events, Incident reporting, Vigilance, post market, FSCA, Compliance, manufacturing, R&D, Research and Development, Quality Management, complaints handling, MDD, MDR, MEDDEV, Competent Authority, ISO 13485, Medical devices, QMS, CAPA, Switzerland, English, German, Nonstop Recruitment

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.