MedTech Consultant - Regulatory Affairs & Quality Assurance

Publiceringsdatum: 2026-09-19

Söker du efter ett jobb inom yrken med teknisk inriktning-sektorn? Axiom Biotek AB är på jakt efter en skicklig kvalitetsingenjör, kemiteknik/kvalitetstekniker, kemiteknik och du kan vara rätt person för jobbet. Vill du arbeta heltid hos Axiom Biotek AB? Just nu letar de efter någon som vill ha en tjänst tills vidare.

Om du redan bor i närheten av Åre, är det här din chans att söka ett spännande jobb Axiom Biotek AB har just nu ett ledigt jobb som kvalitetsingenjör, kemiteknik/kvalitetstekniker, kemiteknik. Axiom Biotek AB letar efter erfaren kvalitetsingenjör, kemiteknik/kvalitetstekniker, kemiteknik som kan ansluta till deras team. Sista ansökningsdag är onsdag den trettionde september 2026.

---

Jobbannons

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 judgement 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