Quality Assurance and Compliance Lead

5 days ago


Gothenburg, Västra Götaland, Sweden Randstad Full time

Randstad is currently looking for a highly skilled Senior Regulatory Affairs Specialist to support the growth and development of our dynamic team.

This position will focus on ensuring that all products meet the highest industry standards and comply with relevant regulations.

Main Responsibilities:
  • Maintain oversight of quality assurance processes and regulatory requirements for medical devices.
  • Collaborate closely with cross-functional teams including R&D, manufacturing, and product management.
  • Develop, implement, and continuously improve quality systems and regulatory strategies.
Requirements:
  • Bachelor's degree in a relevant field such as life science or engineering.
  • No less than 5 years of experience in quality assurance and regulatory affairs in the medical device industry.
  • Extensive knowledge of international standards and guidelines including ISO 13485.
  • Familiarity with relevant regulations such as MDR and 21CFR Part 820.


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