Regulatory Affairs and Quality Specialist

Created by: Medtronic
Added: 08.11.2019

Advert description

Careers that Change Lives

A Day in the Life

Responsibilities
  • Handling of routine regulatory and quality related inquiries of Swiss customers and MDT employees
  • Processing (incl. translation into English language) of incoming Swiss Competent Authority inquiries
  • Support the roll-out of and follow up on 'Field Safety Corrective Actions' in Switzerland
  • Execute 'Product Hold Orders' in Switzerland
  • Support of the Austrian organization in case of absence of the Austrian counterpart in case of time sensitive activities related to the topics mentioned above
  • Monitoring of the Swiss regulatory framework and impact assessment of upcoming changes
  • Support maintenance and further development of the QM system according to EN ISO 13485:2016 and ISO 9001:2015
  • Support creation, verification and release of QM documents
  • Support coordination and monitoring of corrective and preventive actions (CAPA)
  • Monitoring and control of suppliers / distributors
  • Preparation and analysis of relevant data for regular QM review meetings with management
  • Planning and implementation of training courses
  • Close cooperation with colleagues within the Swiss Sales Organization as well as international
Requirements
  • Knowledge of the relevant medical device legislation and corresponding standards (e.g. EN ISO 13485:2016)
  • Degree in Engineering, Life-science, Biology or another relevant degree
  • IT skills (standard office management tools)
  • Preferably work experience in similar field (e.g. medical device industry or competent authority)
  • Language skills: very good command of the German, English (and ideally French) language (spoken and written)
  • Communication/Presentation skills
  • Analytical/Problem-solving skills
About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Specific details

Type of Contract Full time
Preferred Education Bachelor's
Level of Experience 2-5 years

Location

Switzerland, Europe
Bern