Quality Assurance & Regulatory Affairs Specialist

Job description

Are you passionate about combining quality, compliance, and MedTech innovation to make a real difference in healthcare?

At Sigma LifeTech in Gothenburg, we work with advanced Life Science and MedTech solutions where engineering and regulatory excellence go hand in hand. We are now looking to strengthen our team with a QA/RA Specialist who wants to contribute to developing safe, effective, and compliant medical technologies that improve patients’ lives.

In this role, you will be part of a collaborative environment where quality and regulatory work is tightly integrated with product development. You will support both ongoing projects and long-term improvements of processes and systems, ensuring that our solutions meet the high standards required within the MedTech industry.

What you will be working with

You will take an active role in maintaining and developing quality and regulatory practices across projects and organizations. This includes contributing to quality management systems, supporting regulatory strategies, and ensuring compliance with relevant standards and regulations throughout the product lifecycle.

You will also collaborate closely with engineering and development teams, helping to ensure that quality requirements are embedded early and consistently in the development process.

Your responsibilities may include

• Contributing to daily QA/RA activities within project teams
• Supporting maintenance and continuous improvement of quality management systems
• Participating in implementation of new regulatory and standard requirements
• Supporting product documentation and regulatory submissions
• Working with applicable regulations such as MDR, MDD, FDA requirements (including 510(k) where relevant)
• Collaborating with R&D teams to ensure quality is built into development processes

Basic qualifications

• University degree in engineering, life sciences, or a related technical field
• Several years of experience in quality assurance and/or regulatory affairs within MedTech or a similarly regulated industry
• Experience working with quality management systems (e.g., ISO 13485 or equivalent)
• Knowledge of regulatory frameworks such as MDR and MDD
• Familiarity with FDA requirements, including 510(k), is considered an advantage
• Experience with CE marking and product registration processes is a plus
• Strong ability to work with technical documentation and regulatory compliance requirements
• Excellent communication skills in both Swedish and English, written and spoken
• Ability to work in a structured, detail-oriented, and quality-driven manner
• Eligibility to pass security clearance requirements (if applicable to assignments)

As a person you are

You are proactive and take ownership of your work, but you also appreciate collaboration and knowledge sharing. You are detail-oriented without losing sight of the bigger picture, and you feel comfortable working in environments where priorities can evolve.

Most importantly, you are motivated by the idea of contributing to technology that has a real impact on patients’ lives.

We offer:

Sigma Industry LifeTech have extensive hardware and software knowledge and are fully equipped to designand simualate complete products and tech solutions in-house. Our projects innovate and transform businesses and design new products and services within the areas of Life Science, MedTech, Consumer products, R&D, Laboratory, Project leading and Biomechanics.

Sigma Industry LifeTech AB was spun out in 2026 to focus on the Life Science & MedTech industry. With us you will have the opportunity to develop cutting edge technology for market leaders and some of the most new-thinking customers who are really pushing the boundaries of the MedTech field. Our Sigma Industry LifeTech company culture, which is all about sharing experiences and working together – you will never work alone.

• An international working environment
• A value-based organization with a lot of trust – we will make mistakes, you will too - that’s how we learn and develop!
• Creative environment – we want your ideas to have an impact on us!
• Travels & Events!

More information

For more information please contact

Hanna Lauvdal,
hanna.lauvdal@sigma.se

• Position

  Quality Assurance & Regulatory Affairs Specialist

• Company

  Sigma Industry LifeTech

• Location

  Göteborg, Sweden

• Competence area

  Life Science, QA & Validation

• Publication date

  2026-04-16

• Expiration date

  2026-04-30

• Contact

  Hanna Lauvdal, hanna.lauvdal@sigma.se, +46706024360