Medical Device Quality Assurance & Regulatory Affairs Specialist

Air Liquide; Bromma; On-site; SEK 700,000 - 900,000; Full time

Job summary

Nordic Infucare, now part of Air Liquide, seeks a Medical Device Quality Assurance & Regulatory Affairs Specialist in Sweden to ensure MDR/IVDR compliance and maintain the QMS. You will review materials, audits, and liaison with authorities, with a split focus 60% QA and 40% RA.

The ideal candidate holds a Bachelor in Pharmaceutical Science or equivalent with 3–5 years in life science and experience with MDR/IVDR and ISO 13485. Some travel for external audits may be required.

Qualifications

• Bachelor in Pharmaceutical Science or equivalent.
• 3–5 years experience in life science.
• Experience with MDR 2017/745 and IVDR 2017/746, and ISO 13485.

Responsibilities

• Act as main liaison for regulatory affairs with authorities.
• Maintain and improve QMS procedures and CAPA program.
• Review marketing materials, product labels, and IFUs for compliance.
• Audit outsourced distribution partners and host MDR audits.

Skills

Regulatory affairs

Quality Assurance

QMS

CAPA

Audits

Regulatory liaison

Education

Bachelor of Pharmaceutical Science

Tools

ISO 13485

Job description

Nordic Infucare started its journey as an entrepreneurial company with a focus on doing things differently. The business was established to offer specialized treatments for people living with chronic diseases, with the goal of simplifying life and improving patient outcomes. By bridging the gap between medical technology, pharmaceuticals and daily reality, we work toward making life easier for those we serve.Since the start in 2002, we have grown into a company with more than 100 employees. Today, we are a part of the Air Liquide group, and the patient’s quality of life remains the guide for our actions.At Nordic Infucare, we share a passion for solving problems and a genuine drive to make a difference. Our focus is on simplifying life for patients, ensuring that complex medical needs become easier to manage. We believe that we achieve the best results by empowering our people and providing the space for creativity.How will you CONTRIBUTE and GROW?The Medical Device Quality Assurance & Regulatory Affairs Specialist ensures NordicInfu Care complies with Nordic and EU regulations applicable for MD distributors, such as Medical Device (MDR 2017/745) and In Vitro Diagnostic (IVDR 2017/746). This role supports the management of the Quality Management System (QMS), acts as the primary regulatory liaison, and oversees end-to-end product distribution compliance.Role Split: 60% Quality Assurance and 40% Regulatory AffairsRegulatory Affairs (RA): Act as the main liaison for business partners and Competent Authorities. Review marketing materials, product labels, and IFUs for Nordic local compliance. Submit agency reports, provide strategic regulatory guidance, and implement legislative updates. Ensure distribution of MDR/IVDR compliant products.Quality Assurance (QA) & QMS: Maintain and improve QMS procedures. Review Distribution and Quality Agreements. Lead and support the management of Field Safety Notices (FSNs), including internal and external partner support and communication to National Competent Authorities. Handle Deviations and Corrective and Preventive Actions (CAPAs) for our Medical device business. Close collaboration with other departments, such as Customer Support, Purchase &Logistics and Marketing. Audit outsourced distribution partners to ensure MDR/contract compliance. Host external MDR audits/inspections and manage all subsequent Corrective and Preventive Actions (CAPAs). Act as Medical Device Distribution expert.Are you a MATCH?Minimum Degree of Bachelor of Pharmaceutical Science or equivalent.Experience: Minimum 3–5 years of experience within life science. Experience with the regulatory requirements for Medical Devices (MDR 2017/745, IVDR 2017/746) and the ISO 13485 standard. Experience working in large companies and with large corporate processes is a merit. Experience in pharma product distribution/manufacturing is a merit. Regulatory compliance of marketing materials is desirable, but not requiredAnalytical & Structured: Drives operational precision through a rigorous, data-driven, and highly organized approach.Collaborative & Composed: Maintains a calm demeanor and leverages strong, cross-functional communication to foster consensus and team stability.Strategic & Detail-Oriented: Balances meticulous attention to detail with a comprehensive, big-picture view of the broader business.Ability to limited travels for external audits.As our business is highly influenced by Gemini initiatives, an interest in AI or a technical skill in this area is recommended.#LI-MC1Our Differences make our PerformanceAt Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world.We welcome and consider applications from all qualified applicants, regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world.