Requirements

Required education level
Ad. Federal PET / Fed. PET Diploma, Bachelor, Master
Required experience
Between 3 and 5 years
Required language knowledge
English German
Required skills
Compliance compliance COMPLIANCE post market surveillance ISO 13485 vigilance Complaints specialist complaints Specialist Vigilance adverse effects

Details

Location
Other countries
Term of employment
Full time
Sector
Medical technology
Professions
Regulatory Affairs Management / Project Managemen... Production Research & Development / Labor...

Description

QA/Vigilance Manager with supervision - Key role - Adverse event reporting - English & German essential

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 company that forms a strong part of work ensuring compliance to the MDR and developing/upgrading the QMS.

This is a temporary 12 months position, and with commitment to fill the role as soon as possible, independent of the pandemic

  • Immediate management of Field Safety Corrective actions and follow up
  • Daily management and guidance of 2 staff
  • 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 & German is essential

For more information on this vacancy, please contact the Senior Consultant Andrew Boroky on 0041 43 50 80 817, and email him your resume in WORD format to A.boroky@nonstopconsulting.com.

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.

NonStop Consulting
May 17, 2020

Contact info

NonStop Consulting
Andrew Boroky
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Not available