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Medtech Compliance Specialist – Knightec Group

Knightec Group Compliance and Management AB

Skåne län, Malmö

Previous experience is desired

38 days left
to apply for the job

Why this job is for you

At Knightec Group, we understand that improving patient quality of life by ensuring the safety of medical technology products and pharmaceuticals is of utmost importance. By balancing quality and regulatory compliance throughout the product and production development process, you play a crucial role in introducing new technology and more efficient medical equipment and medicines to the market.

Your development is important to us. Your ambition and drive steer the direction, while we provide you with the tools and conditions for success. Through mentoring, competence-sharing forums, knowledge exchange, and a team-oriented working approach, you will have access to the combined expertise within Knightec Group. You will become part of our national initiative in Medtech Compliance, where you will, among other things, have the opportunity to participate in training and certifications.

Within our business area Compliance & Management, we support an efficient transition to digital, sustainable, and secure solutions through expert knowledge in areas such as quality, safety, sustainability, and project management.

Responsibilities

In this role, you will work on varied and developmental assignments for companies of different character, where your expertise will be put to good use.

  • You will improve the quality of life for patients through safe medical technology products and pharmaceuticals.
  • You strive to find the right balance between quality and regulatory compliance during the product development process.
  • You strive to find the right balance between quality and regulatory compliance in a strictly regulated production environment, such as GMP.
  • You want to be a key part of introducing new technology and more efficient medical equipment to the market.
  • You want to utilize your full competence in varied projects, ranging from startups to well-established international companies.
  • You have expertise in Design Control, technical documentation, Quality Assurance, or regulatory requirements and wish to take significant responsibility in your assignments.
  • You value working in an environment characterized by trust, transparency, and collaboration.

Qualifications

Your most important qualities are your willingness to learn and share your knowledge with others. Since our ambition is to help our customers take the next step into the future through digital tools, we look for someone with an interest in new technology and digitalization. It is particularly interesting if you have experience or interest in working with software quality assurance or connected equipment.

You also have:

  • A Bachelor's or Master's degree in Biotechnology, Medical Technology, Chemical Engineering, or similar.
  • Experience working with product development quality within the medical technology industry, such as Design Control, CE marking, Quality Assurance, Regulatory Affairs, or quality management systems.
  • Experience working in a regulated production environment, for example, within the pharmaceutical industry.
  • Good knowledge of relevant regulatory requirements and standards such as MDD/MDR, ISO 13485, ISO 14971, IEC 62304, and GMP.
  • Fluent proficiency in Swedish and English.

An exciting journey with Knightec Group

Semcon and Knightec have joined forces as Knightec Group. Together, we form Northern Europe's leading strategic partner in product and digital service development – how cool is that?

With a unique combination of cross-functional expertise and a holistic understanding of business, we help our customers realize their strategies – from idea to finished solution. At Knightec Group, we have the competence, attitude, and drive required to take on the most challenging and innovative projects.

For our employees, this means fantastic opportunities to help shape the future through meaningful projects at the absolute forefront of technology. Here, you will not only develop and grow but also become part of something bigger.

Does this sound like the place for you? Join us on an exciting journey!

Practical Information

This is a permanent position with a six-month probationary period, located at our office in Malmö (Ångbåtsbron 1) or our office in Helsingborg (Stortorget 11). Travel to our customers may occur as part of the role. Start date is as soon as possible or by agreement.

Please submit your application as soon as possible, but no later than 2026-08-10. 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 career page.

We look forward to hearing from you!

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