Job Detail

• Job TitleQA/RA Med Tech – New MDR


• Vacancy Reference Number11102


• Work SiteSwitzerland / | CHE - All Regions / Basel


• Contract TypePermanent [Full-Time]

Our offer

• A permanent contract with the leader in innovation and high-tech engineering consulting


• A multi-stage model with career opportunities through specialization prospects, as well as with over 45'000 consultants around the world and revenue of EUR. 2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).


• In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.


• Altran deploys its expertise particularly in:
  
  
  
  • Life Sciences (Pharma, Biotech, and Medical Devices),
  
  
  • Industry, Aerospace, Automotive, Energy, Railways,
  
  
  • Financial Services: P&C Insurance, Health Insurance, Reinsurance, Banking
  
  
  • Telecoms
  
  
  • Public sector
  
  

Your role

• Participate on (MDR implementation) by representing and reinforcing, Quality Assurance and Regulatory Affairs requirements


• Work in a multidisciplinary group for Technical File adaption according to MDR 2017/745


• Ensure that the technical documentation supporting the CE mark complies with MDD 93/42/EEC


• Create and maintain Technical Files/Design Dossiers


• Support the International Regulatory Affairs Team in preparation of International Submissions


• Interaction with authorities, notified bodies and any other approving bodies that will be relevant


• Assessment of potential risks and the classification of the medical device in accordance with MDD and MDR


• Support and consultation of the Departments in regard of interpretation of regulatory rules/laws/guidelines

Your profile

• MSc/PhD degree in Pharmacy, Regulatory field


• Minimum 5 years of professional experience in Regulatory Affairs and/or Quality Management


• Detailed knowledge about the standards and directives for Medical Devices such as ISO 13485, ISO 14971, MDD 93/42/EEC and MDR 2017/745


• Experience from Audits would be a plus


• Advanced knowledge of excel and data analysis would be a plus


• Fluency in English, German would be an asset