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Quality & Regulatory Affairs Manager (m/f/d) (EN)

[14357]
Quality, Regulatory Affairs, ISO 13485, CE

Job title: Quality & Regulatory Affairs Manager (m/f/d) Industry: Medical Devices Skills: Quality, Regulatory, CE Marking, ISO 13485 Start date: ASAP Location: Zurich, Switzerland   The Aristo Group is a Recruitment focused solution provider in the life sciences industry. Our goal is to find the “perfect match” for our customers and candidates. We are now looking for an experienced QA/RA Manager to join a Global MedTech company to work on innovative products benefiting the healthcare of millions.     Main duties ·Overseeing and implementing regulatory compliance for all medical devices in portfolio (ISO 13485) ·Handling the submission, maintenance, and renewal of product approvals in various sales markets ·Engaging and maintaining communication with relevant regulatory authorities ·Identifying, generating, and renewing product approvals within sales markets ·Assisting in the planning and execution of both internal and external audits ·Collaborating in the management review process ·Conducting post-market surveillance and managing risks effectively     Qualifications ·Bachelors degree in a scientific field ·Min 5 years of professional experience in Regulatory Affairs (RA) and Quality Management (QM) ·Demonstrated enjoyment and proficiency in managing and maintaining quality documents with precision ·Adaptable team player with a structured approach, capable of thriving in dynamic work environments ·Ability to perform well under pressure and adeptly prioritize tasks ·Fluent in English, French or German advantageous     For further information about this position, please apply with your CV or contact me directly via linkedIn.   *Please note, only those with the right to work in Switzerland can apply*

Job title: Quality & Regulatory Affairs Manager (m/f/d)

Industry: Medical Devices

Skills: Quality, Regulatory, CE Marking, ISO 13485

Start date: ASAP

Location: Zurich, Switzerland

 

The Aristo Group is a Recruitment focused solution provider in the life sciences industry. Our goal is to find the “perfect match” for our customers and candidates.

We are now looking for an experienced QA/RA Manager to join a Global MedTech company to work on innovative products benefiting the healthcare of millions.

 

 

Main duties

  • Overseeing and implementing regulatory compliance for all medical devices in portfolio (ISO 13485)
  • Handling the submission, maintenance, and renewal of product approvals in various sales markets
  • Engaging and maintaining communication with relevant regulatory authorities
  • Identifying, generating, and renewing product approvals within sales markets
  • Assisting in the planning and execution of both internal and external audits
  • Collaborating in the management review process
  • Conducting post-market surveillance and managing risks effectively

 

 

Qualifications

  • Bachelors degree in a scientific field
  • Min 5 years of professional experience in Regulatory Affairs (RA) and Quality Management (QM)
  • Demonstrated enjoyment and proficiency in managing and maintaining quality documents with precision
  • Adaptable team player with a structured approach, capable of thriving in dynamic work environments
  • Ability to perform well under pressure and adeptly prioritize tasks
  • Fluent in English, French or German advantageous

 

 

For further information about this position, please apply with your CV or contact me directly via linkedIn.

 

*Please note, only those with the right to work in Switzerland can apply*

map Zürich, Switzerland date_range 13.03.2024 update Permanent
Direct contact

Antony Polito

Senior Recruitment Consultant
mail a.polito@aristo-group.ch
phone +41 44 27439 00


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