Medical Device Compliance Specialist

13 hours ago


Gothenburg, Västra Götaland, Sweden Randstad - Göteborg Full time
Job Description

We are seeking a highly skilled Medical Device Compliance Specialist to join our team at Randstad - Göteborg. As a key member of our quality assurance department, you will play a crucial role in ensuring the compliance of our medical devices with regulatory requirements.

Your primary responsibilities will include:

  • Overseeing quality assurance processes and ensuring compliance with relevant regulations, including MDR and 21CFR Part 820.
  • Managing product registrations for global markets and regulatory releases.
  • Hosting external audits and inspections, as well as performing internal and supplier audits.
  • Ensuring the implementation and improvement of quality systems and regulatory strategies within the company.

To be successful in this role, you will need to have:

  • A university degree in life science, engineering, or a related field.
  • Comprehensive experience (+5 years) in both operational and strategic responsibility for QA and RA in the medical device industry.
  • In-depth knowledge and experience in registering products in different markets globally.
  • Expertise in relevant regulations, including MDR and 21CFR Part 820, ISO 13485, and other international standards and guidelines.


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