MedTech Consultant - Regulatory Affairs & Quality Assurance

Axiom Biotek AB · plný úvazek

Åre, Švédsko

About the company Axiom Biotek is a consultancy company within quality and regulatory assurance (QA/RA) for medical devices, IVD and combination product manufacturers. We help companies build quality management systems, prepare technical documentation and regulatory submissions, and take clients through Notified Body certification. Our client base spans both pharmaceutical and medical device manufacturers, in addition to combination products. The role We are looking for a MedTech Consultant to lead our medtech practice. You will own client engagements end to end, from regulatory strategy to audit readiness. This is a senior, client-facing role in a small company. You will be trusted with your own clients from the start, and your regulatory judgment will carry real weight in what we take on. Main responsibilities Advise clients on regulatory strategy and route to market across EU MDR, IVDR, FDA and UK requirements Prepare and review technical documentation, declarations of conformity and regulatory submissions, including 510(k) and De Novo Establish and maintain ISO 13485 and FDA QMSR compliant quality management systems, and support clients operating GMP pharmaceutical quality systems Plan and conduct internal and supplier audits; prepare clients for Notified Body and FDA inspections and support them during assessment Configure and administer client electronic quality management systems Requirements A degree in life sciences, engineering or a related technical discipline 5+ years of experience in regulatory affairs and quality assurance for medical devices or IVDs Demonstrable experience across both the pharmaceutical and medical device sectors, including GMP and ISO 13485 quality systems Hands-on working experience with Advantum and Greenlight Guru electronic quality management systems Working knowledge of EU MDR 2017/745, ISO 13485:2016 and ISO 14971 Experience preparing technical documentation and leading or supporting certification audits Fluent professional English, written and spoken