Why this job is for you
At Knightec Group, you get to help shape how connected pharmaceutical and medical technology products are developed to be safe, compliant and ready for tomorrow's requirements.

At our business area Compliance & Management in Gothenburg, we are currently building an offering at the intersection of product regulations such as MDR/IVDR and GxP, and new EU requirements for cybersecurity and AI, including the Cyber Resilience Act (CRA) and the AI Act.

We are looking for you who want to drive this development together with our clients in pharma and medtech - and at the same time help shape how Knightec Group builds its offering in this area.

Areas of responsibility
You will, among other things:

• Lead and carry out GAP analyses against the CRA and AI Act for connected medical technology products and digital pharmaceutical solutions

• Support clients in classifying AI systems under the AI Act (including the link to MDR/IVDR classification of medical technology AI products)

• Develop and review regulatory documentation, risk and cybersecurity processes throughout the product lifecycle

• Build bridges between quality/regulatory affairs and technical cybersecurity expertise in the clients' organisations

• Help shape Knightec's offering in this area in Gothenburg
  
  

Qualifications
We believe you have experience of compliance, quality or regulatory work within pharma and/or medtech and thrive in a role where you combine regulatory affairs, technology and business.

We would welcome it if you have:

• Experience of the Cyber Resilience Act (CRA) and/or AI Act, particularly linked to connected or AI-driven medical technology products

• Experience of regulatory work within pharma and/or medtech, for example MDR/IVDR, ISO 13485, GxP or 21 CFR 820

• Practical experience of IEC 62304 and/or IEC 81001-5-1, ideally from work establishing or developing software and cybersecurity processes together with development teams

• Experience of regulatory requirements and requirements management (RA)

• Understanding of cybersecurity regulations and experience of gap analyses against standards or regulatory requirements

• Experience of AI/machine learning and understanding of how AI systems are trained, validated and governed, for example within data governance, explainability and human oversight

• Experience of ISO 14971 and/or GAMP 5

• A structured and analytical way of working and the ability to communicate complex regulatory requirements in a clear and understandable way

• Ability to collaborate with different roles and functions and to work effectively in different organisations and project environments
  
  

An exciting journey with Knightec Group
Knightec Group is today one of Northern Europe's leading strategic partners in product and digital service development - isn't that impressive?

By combining engineering expertise, digital expertise and business understanding, we help our clients turn new technology into real solutions that create value. We work at the intersection of business strategy and technology development and support our clients throughout the journey - from the first ideas to development, implementation and further development.

At Knightec Group, people with different perspectives, experiences and areas of specialisation come together. Together we create innovation that makes a real difference - for companies, people and society at large.

For our employees, this means great opportunities to help shape the solutions of the future through meaningful projects at the very forefront of technology. Here you will not only develop and grow in your role - you also become part of a team where curiosity, collaboration and the courage to challenge drive us forward.

Does this sound like the place for you? Join us on our continued journey!

Practical information
This is a permanent position with a six-month probationary period, based at our office in Gothenburg, Lindholmsallén 2. Travel to clients may occur as part of the role. Start date is as soon as possible or by agreement.

Submit your application as soon as possible, but no later than 2026-10-18. If you have any questions about the position, you are welcome to contact Talent Acquisition Specialist, Oliver Rydberg. Please note that, due to GDPR, we only accept applications via our careers page.

We look forward to hearing from you!