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Senior Regulatory Affairs Specialist (Medical Devices)

Our customer is a young and dynamic company focusing on developing technologies to generate antimicrobial properties to a range of surfaces and substrates. The HQ is in Zug / Switzerland and the company is represented in Europe, the USA, Asia, and the Middle East.

The company is constantly growing and building up new markets, therefore we are looking for an equally dynamic person as



Senior Regulatory Affairs Specialist (MDD and MDR)

Main Tasks:

  • Responsible for compliance legislation with a focus on MDD and MDR
  • Provision and maintenance of internal and external security documentation for our products (e.g. technical file, Labeling, packaging, SOPs, quality management file)
  • Collaborate with different internal and external labs to get technical data
  • Responsibility for preparing, implementing, communicating, and coordinating regulatory projects and work closely with clients and authorities
  • Responsible for registration and notification of medical products according to the local (and international) regulatory frameworks and develop and maintain regulatory knowledge of European
  • Interaction with the Technology and Business Development teams in developing a regulatory strategy


Your Profile:

  • BA / MA in biology and microbiology
  • 3 – 7 years of experience in the medical device industry
  • Working experience in CE marking, notification and national registrations of medical devices towards the European Commission / National Competent Authorities
  • MDR experience (mandatory) also knowledge of the biocidal regulation (BPR) and chemical regulation is a strong plus
  • experience of writing key documents such as Risk Assessment Report, Clinical Evaluation Report or Post Market Surveillance report
  • English proficient, any other language is an asset
  • Flexibility and ability to think and act beyond the borders of RA
  • Good interpersonal skills, teamwork, multi-cultural compatibility
  • excellent communication skills
  • Motivated and self-driven attitude
  • Experience with Quality Management System ISO 13485 and cosmetics regulations is benefit

 

Our company is offering a very dynamic and professional environment, good team spirit and the possibility to develop your talent and career!

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