Quality Assurance and Regulatory Expert
13 hours ago
Randstad - Göteborg is a dynamic and rapidly growing MedTech company committed to developing innovative medical devices that improve patient outcomes. We are looking for a highly motivated and experienced Mid-Senior Quality Assurance/Regulatory Affairs (QA/RA) Specialist to join our team.
This position offers an exciting opportunity to contribute to the development of cutting-edge products while ensuring compliance with the highest industry standards. You will work closely with cross-functional teams, including R&D, manufacturing, and product management, to support the successful commercialization of products and ensure ongoing regulatory compliance.
You will be responsible for overseeing quality assurance processes and ensuring compliance with regulatory requirements. This includes managing product registrations for global markets and regulatory releases, hosting external audits and inspections, and performing internal and supplier audits. You will also ensure the implementation and improvement of quality systems and regulatory strategies within the company.
The ideal candidate will have a strong background in quality assurance and regulatory affairs, with comprehensive experience (+5 years) in both operational and strategic responsibility for QA and RA in the medical device industry. You will need to have in-depth knowledge and experience in registering products in different markets globally, as well as expertise in relevant regulations, including MDR and 21CFR Part 820, ISO 13485, and other international standards and guidelines.
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