Regulatory Compliance Specialist

5 days ago


Gothenburg, Västra Götaland, Sweden Randstad - Göteborg Full time
Key Responsibilities of a Mid-Senior Quality Assurance and Regulatory Affairs Specialist

The ideal candidate will play a pivotal role in overseeing quality assurance processes, ensuring seamless compliance with regulatory requirements for medical devices.

This professional will work closely with cross-functional teams to drive the successful commercialization of products, guaranteeing ongoing regulatory compliance.

Key responsibilities include:

  • Product inspection and testing, ensuring adherence to industry standards.
  • Hosting external audits and inspections, maintaining a high level of professionalism.
  • Conducting internal and supplier audits, identifying areas for improvement.
  • Ensuring timely product registrations as required per market.
  • Managing the Quality Management System (QMS), promoting efficiency and effectiveness.
Qualifications

To be considered for this position, candidates should possess the following qualifications:

  • University degree in life science, engineering, or other relevant field, providing a strong foundation for success.
  • Comprehensive experience (+5 years) in both operational and strategic responsibility for QA and RA in the medical device industry.
  • Expertise in registering products in different markets globally, leveraging knowledge to drive business growth.
  • Knowledge of relevant regulations, including MDR, 21CFR Part 820, ISO 13485, ISO 14971, and ISO 11135.


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