Requirements

Required education level
Compulsory education, CFC/EFZ, Bac. / Federal Vocational Bac.
Required experience
Between 3 and 5 years
Required language knowledge
English German
Required skills
Compliance Regulatory English Medical Devices Switzerland MEDICAL DEVICES SWITZERLAND compliance post market surveillance medical devices switzerland english Medical devices quality assurance Audit CAPA 21 CFR 820 Switzerland Quality Assurance ENGLISH Complaints audit REGULATORY complaints Quality assurance MDD german regulatory product recalls MDR QUALITY ASSURANCE Audit COMPLIANCE Vigilance adverse event incident German ISO 13485 / IEC 60601 FSCA

Details

Location
Other countries
Term of employment
Full time
Sector
Medical technology
Professions
Management / Project Managemen... Nurse / Midwife Laboratory / Analysis Medicine (Doctors, Dentist…) Care staff / nurse Medical-Technical Staff Physiotherapist / Occupational... Psychiatry Medical-Secretarial / Assistan...

Description

Vigilance Specialist - Scenic Switzerland - High Tech products - English and German a MUST

Our client is a globally active medical devices manufacturer - in a leading market position, growing, and with it the Quality department. On top of their 'wanted' list is a Vigilance specialist - a key role going forward, in addressing complaint and vigilance reporting processes, and ultimately in reducing the complaints themselves.

More specifically, this role will hold responsibility for vigilance reporting and assurance of the submission of the reports to regulatory agencies within required time lines. The person will drive the clarification of complaints including distributors to ensure they are correctly prioritised, and interact with health care providers and regulatory agencies to ensure all questions are addressed within established time-frames.

Other responsibilities include

  • Support to product managers throughout the life cycle of the product in regulatory terms to ensure product compliance with medical device requirements
  • Definition of safety measures (FSCA), active participation in product recalls and recall communications to markets and health authorities
  • Involvement in internal and external audits and the audit responses
  • Process improvement wrt Vigilance reporting

Above all this position requires a solid knowledge of complaints handling processes and vigilance reporting within the medical devices industry. While the actual complaints will be addressed by SMEs on site, some technical know how or background would be useful for this role as the products are electro-mechanical in nature.

This is an urgent requirement - The client is committed to closing off this vacancy

For more information on this vacancy, or any other QA opportunities within the Swiss Medical Devices sector, please contact the Senior Consultant Andrew Boroky on 0041 43 50 80 817, or email him at a.boroky@nonstopconsulting.com together with scanned certifications of training and Arbeits Zeugnisse.

KEY WORDS: Vigilance, adverse event, incident, post market surveillance, Complaints, Switzerland, Quality Assurance, Compliance, CAPA, Medical Devices, German, English, 21 CFR 820, MDR, MDD, ISO 13485 / IEC 60601, product recalls, FSCA, audit, regulatory, health authorities, distributor, notified body, 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.

NonStop Consulting
Jul 28, 2020

Contact info

NonStop Consulting
Andrew Boroky
p0w yw y- z7 )y( 07g
Not available