Quality Assurance and Regulatory Affairs Specialist

Job description
Are you an enthusiastic quality assurance and regulatory affairs specialist eager to join a fast paced growing Med Tech company in the Gothenburg area?


Our customer company is a dynamic and rapidly growing MedTech company committed to developing innovative medical devices that improve patient outcomes. As they continue to scale, they are looking for a highly motivated and experienced Mid-Senior Quality Assurance/Regulatory Affairs (QA/RA) Specialist to join their team. This position offers an exciting opportunity to contribute to the development of cutting-edge products while ensuring compliance with the highest industry standards.


As a Mid-Senior QA/RA Specialist, you will play a key role in overseeing quality assurance processes and ensuring compliance with regulatory requirements for medical devices. 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. Your expertise will contribute to the development, implementation, and improvement of quality systems and regulatory strategies within the company.


This is a consulting assignment within Randstad Life Sciences which is specializing in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.


If you are ready to make a difference and join our customer exciting growth journey, apply before the 31st of January 2025. Selection and interviews will be ongoing. The starting date will be agreed upon by all parties. For more information: Please contact Meriem Echbarthi, PhD meriem.echbarthi@randstad.se.

Responsibilities
Be a key component of the QA/RA department of our customer with all related entities, including related budget.
Product inspection and testing.
Host external audits and inspections.
Perform internal and supplier audits.
Ensure product registrations as required per market.
Overall responsible for QMS.
Register products on global markets, regulatory release.
Approve quality-related documents, see SOP-0068.
Report to Management review meetings.


Qualifications
University degree in life science, engineering, or other relevant area.
Comprehensive experience (+5 years) of 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.
In-depth knowledge and experience of relevant regulations; MDR and 21CFR Part 820, the standard for Quality Management System, ISO 13485, and other international standards and guidelines, such as ISO 14971, and ISO 11135.
Leadership experience.


About the company

Randstad
At Randstad, we see the possible in people. With business all over Sweden and in all areas of expertise, we help people find work that feels good, where they get the opportunity to develop and realize their true potential. With close to 600 000 employees in 38 countries, Randstad is the global leader in the HR services industry. Our mission is to become the world’s most valued working life partner. By combining our passion for people with the power of today’s technology, we support people and organizations in realizing their true potential. We call it Human Forward.