Senior QA & RA Consultant – Medical Devices & IVD

Location: Finland Senior QA & RA Consultant – Medical Devices & IVD We are looking for an experienced QA & RA professional to join Aurevia in a permanent, full-time position. As a Senior QA & RA Consultant, you will support national and international medical device and IVD manufacturers in navigating complex quality and regulatory requirements across the full product lifecycle. The role combines strategic regulatory guidance with hands-on operational support. As a trusted advisor, you will work closely with clients ranging from start-ups to large global companies, providing high-quality services throughout the entire lifecycle of medical devices and quality management systems. The position isbased at our Lund or Kista office, with flexibility for remote work. You will work in close collaboration with our QA/RA teams in Stockholm and Finland. At Aurevia, you become part of a collaborative, professional, and highly skilled team. • Provide expert regulatory and quality guidance across the full lifecycle of medical devices and IVDs. • Develop and support regulatory strategies for EU, USA, and other global markets. • Build, maintain, and continuously improve Quality Management Systems in accordance with ISO 13485 and applicable regulations. • Support CE-marking processes under MDR and IVDR, including Technical Documentation and conformity assessments. • Support FDA regulatory processes, including 510(k) and PMA submissions. • Provide hands-on support in risk management (ISO 14971), process validation, software validation, biocompatibility, usability engineering, and electrical safety documentation. • Conduct gap analyses of technical documentation, clinical/performance evaluations, and lifecycle documentation. • Plan and conduct internal audits and support clients during audits and inspections by Notified Bodies and regulatory authorities. • Support remediation activities related to audit findings, compliance gaps, or warning letters. • Deliver internal and external trainings within areas of your QA/RA expertise. • Act in external roles within clients’ quality and regulatory organizations. • Share knowledge internally and mentor colleagues within the Aurevia team. • Represent Aurevia at conferences, regulatory forums, and industry events. • Participate in IEC/ISO standard committees and relevant regulatory or industry working groups. We don’t expect you to check every box! If you’re excited about this role and believe you’d be a great fit, we encourage you to apply. Qualifications • Strong expertise (5+ years) within the medical device and/or IVD industry. • Solid experience in Quality Assurance and Regulatory Affairs (e.g. ISO 13485, ISO 14971, MDR, IVDR). • Experience with biological evaluation in accordance with applicable standards and regulations (e.g. ISO 10993) is considered an advantage. • Specific experience in IVD products is an advantage. • Experience with FDA regulations is an advantage. • University degree in engineering, science, clinical disciplines, or equivalent. • A proactive, service-oriented mindset with the ability to work independently and manage multiple assignments in parallel. • Fluent English skills (spoken and written); Swedish proficiency is an advantage. • Project management experience is an advantage At Aurevia, you will work in diverse and impactful assignments, ranging from large-scale transformation projects to focused expert tasks such as bringing a new medical device to selected markets, establishing a Quality Management System, creating a regulatory strategy, or performing internal audits. You will gain a front-row view of the medical device industry as part of one of the Nordic region’s leading expert organizations in Quality and Regulatory Affairs. Our strong team culture provides an excellent platform for collaboration, knowledge sharing, and professional growth in a constantly evolving regulatory environment. You will work alongside friendly, highly competent colleagues while delivering high-quality services to our broad customer base, including global market leaders and innovative start-ups. At Aurevia, we are the excellence makers — a team of experienced experts in healthcare and health-tech standards and quality. Together, we drive healthcare,… Apply tot his job Apply To this Job