QA/RA Consultant (Maternity cover, with possibility of extension)

We are currently looking for an experienced and dedicated QA/RA Consultant to join us on a maternity cover contract and help strengthen and further develop our work with quality management and regulatory compliance for medical device software.

Who are we?

Trifork Digital Health develops national digital health solutions for the Danish healthcare sector. We are behind some of Denmark’s most widely used digital healthcare solutions, serving both citizens and healthcare professionals. These include the Shared Medication Record (FMK), the My Doctor app (Min Læge), the Danish Vaccination Register, the national telemedicine platform Telma, and the Shared Medication Decision Support system.

We are passionate about creating user-friendly and innovative solutions in close collaboration with our customers and healthcare domain experts. Our goal is to develop technology that improves healthcare workflows while enhancing the individual citizen’s experience of the healthcare system.

About the role

As a QA/RA Consultant, you will support the development and maintenance of quality management and regulatory processes, with a particular focus on Medical Device software (MDSW).

Working at the intersection of technology, healthcare, and compliance, you will collaborate with experienced colleagues, software developers, and customers to help ensure that our products and processes meet relevant quality and regulatory requirements. You will contribute to integrating regulatory considerations throughout the software development lifecycle while developing your expertise in medical device regulations and quality assurance.

The position is based at our Aarhus office, but we also have an office in Copenhagen, and either location is possible.

You will be responsible for

• Maintaining and further developing our Quality Management System (QMS), which is certified in accordance with ISO 13485

• Leading and participating in internal and external audits

• Ensuring compliance with ISO 13485, ISO 14971, IEC 62304, and IEC 62366

• Communicating and presenting regulatory requirements both within and outside the organization

• Advising on the CE marking of medical devices under the Medical Device Regulation (MDR)

We are looking for someone who has

• Experience in quality management

• Solid knowledge of relevant standards and regulations

• Experience with Medical Device software (MDSW)

• A relevant educational background in technology, healthcare, engineering, life sciences, or a related field

Languages

• Fluent in English, both written and spoken

• Fluent in Danish is an advantage, but not a requirement

What do we offer?

Our day-to-day work is characterized by an open and honest atmosphere. We strive to create a work environment that is both challenging and enjoyable. We work in agile, cross-functional teams with a strong focus on collaboration and helping each other succeed, while maintaining close partnerships with our customers to understand their needs and challenges.

We offer excellent opportunities for both professional and personal development through exciting projects, Trifork Hackerdays, conferences, social events, and our annual team trip.

In addition, you can expect:

• An open and informal work environment

• Flexible working hours and the possibility to work from home

• Professional sparring and knowledge sharing with specialists in medical software and regulatory compliance

• Pension scheme and private health insurance

• Lunch arrangement and freshly brewed Italian coffee

Please note

This is a 12-month maternity cover position, with a preferred start date no later than 1 September 2026. There may be an opportunity for extension beyond the initial contract period.

The application deadline is 15 August 2026. Interviews will be conducted on an ongoing basis, so we encourage candidates to apply as soon as possible.

We encourage all interested candidates to apply, even if they do not meet every requirement listed. What matters most to us is your motivation, potential, and willingness to learn.

If you have any questions about the position, please feel free to contact René Hauge Sørensen at rhso@trifork.com.