Om jobbet
On behalf of Axlab A/S, PharmaRelations is looking for a highly skilled Quality & Regulatory Professional with a scientific background and experience in the MedTech industry.
We are seeking a skilled Quality and Regulatory Professional with a scientific background and, preferably, experience in the MedTech industry. The ideal candidate has solid experience in maintaining and updating risk management files, handling product labelling and specifications, and managing technical documentation. A candidate with experience in complaint handling, NC/CAPA processes, post-market surveillance, and other quality assurance activities is preferred.
The candidate possesses a solid understanding of in vitro/medical device regulations across the EU, US, and Canada. The right candidate has experience supporting audits and management reviews and is accustomed to working cross-functionally in manufacturing environments.
Strong communication skills-both written and verbal-are essential, as is the ability to collaborate effectively with suppliers, partners, and internal stakeholders. International experience and a proactive, detail-oriented mindset are strong advantages.
You are required to be in the office at least 3 days per week.
Key Roles and Responsibilities
On a personal level, you are positive, collaborative, and thrive in a role that requires both independent work and teamwork across functions.
About the QA/RA & Market Access Team
The department plays a central role in ensuring that products meet all applicable legislation, standards, and regulatory requirements. QA/RA manage the Quality Management System (QMS), oversee technical documentation, and work closely with production sites to ensure smooth operations and compliance.
QA is responsible for audits, supplier evaluations, complaint handling, and maintaining safety and performance standards. RA ensures compliance with local and international regulations, including registrations, labelling, and market approvals. The Market Access team drives product entry into new and established markets, ensuring alignment across technical, quality, and regulatory standards.
About Axlab A/S:
Axlab A/S is a Danish company headquartered in Vedbæk with around 60 employees worldwide. Since 1993, they have delivered advanced medical equipment and consumables to hospitals and laboratories - with a dedicated focus on pathology. The company collaborates with strategic international partners while also producing unique solutions such as BiopSafe biopsy containers.
Axlab works to improve patient care through innovation, automation, and the optimization of laboratory workflows. Their portfolio ranges from advanced instruments to education and support via Axlab Academy. With strong growth and ambitious goals, Axlab is today one of the leading players in the international pathology market.
In 2018, Axlab became part of DENA A/S through a generational transition, strengthening the company with additional financial resources. As a solid and long-term owner, DENA provides stability and a strong foundation, enabling Axlab to continue its growth journey and deliver lasting results.
Axlab is driven by integrity, innovation, and partnership - and they strive to be an attractive workplace where collaboration, flexibility, and professional development go hand in hand.
The next step - your application
For further information please don't hesitate to reach out to Jens Knud Maarup, Recruitment Manager, +45 5433 4320 (jens.maarup@pharmarelations.dk) or Mette Uth (Head of Commercial Interim) +45 6098 1303 / mette.uth@pharmarelations.dk
Applications will be handled continuously. We look forward to hearing from you!
Due to GDPR, we cannot receive any CVs via e-mail. Please apply via the link below.
We are seeking a skilled Quality and Regulatory Professional with a scientific background and, preferably, experience in the MedTech industry. The ideal candidate has solid experience in maintaining and updating risk management files, handling product labelling and specifications, and managing technical documentation. A candidate with experience in complaint handling, NC/CAPA processes, post-market surveillance, and other quality assurance activities is preferred.
The candidate possesses a solid understanding of in vitro/medical device regulations across the EU, US, and Canada. The right candidate has experience supporting audits and management reviews and is accustomed to working cross-functionally in manufacturing environments.
Strong communication skills-both written and verbal-are essential, as is the ability to collaborate effectively with suppliers, partners, and internal stakeholders. International experience and a proactive, detail-oriented mindset are strong advantages.
You are required to be in the office at least 3 days per week.
Key Roles and Responsibilities
- Maintaining and updating risk management files, both internally and with suppliers
- Preparing and maintaining technical documentation
- Updating and controlling product labelling, specifications, and product changes
- Supporting post-market activities such as trend analysis, evaluation, complaint handling, and NC & CAPA processes
- Supporting audits and management reviews
- Working closely with suppliers and partners, including overseeing and updating Quality Agreements
- Assisting with training of new employees in QA processes
- Contributing to regulatory and market access activities, coordinating with production sites and product management
- A university degree with a scientific background
- Experience from the MedTech/IVD industry is a strong advantage
- Solid knowledge of EU, US, and Canadian regulations for in vitro/medical devices
- Experience with complaint handling, NC/CAPA processes, and post-market surveillance
- Experience supporting audits and management reviews
- Strong written and verbal communication skills
- A proactive, detail-oriented, and action-driven mindset
On a personal level, you are positive, collaborative, and thrive in a role that requires both independent work and teamwork across functions.
About the QA/RA & Market Access Team
The department plays a central role in ensuring that products meet all applicable legislation, standards, and regulatory requirements. QA/RA manage the Quality Management System (QMS), oversee technical documentation, and work closely with production sites to ensure smooth operations and compliance.
QA is responsible for audits, supplier evaluations, complaint handling, and maintaining safety and performance standards. RA ensures compliance with local and international regulations, including registrations, labelling, and market approvals. The Market Access team drives product entry into new and established markets, ensuring alignment across technical, quality, and regulatory standards.
About Axlab A/S:
Axlab A/S is a Danish company headquartered in Vedbæk with around 60 employees worldwide. Since 1993, they have delivered advanced medical equipment and consumables to hospitals and laboratories - with a dedicated focus on pathology. The company collaborates with strategic international partners while also producing unique solutions such as BiopSafe biopsy containers.
Axlab works to improve patient care through innovation, automation, and the optimization of laboratory workflows. Their portfolio ranges from advanced instruments to education and support via Axlab Academy. With strong growth and ambitious goals, Axlab is today one of the leading players in the international pathology market.
In 2018, Axlab became part of DENA A/S through a generational transition, strengthening the company with additional financial resources. As a solid and long-term owner, DENA provides stability and a strong foundation, enabling Axlab to continue its growth journey and deliver lasting results.
Axlab is driven by integrity, innovation, and partnership - and they strive to be an attractive workplace where collaboration, flexibility, and professional development go hand in hand.
The next step - your application
For further information please don't hesitate to reach out to Jens Knud Maarup, Recruitment Manager, +45 5433 4320 (jens.maarup@pharmarelations.dk) or Mette Uth (Head of Commercial Interim) +45 6098 1303 / mette.uth@pharmarelations.dk
Applications will be handled continuously. We look forward to hearing from you!
Due to GDPR, we cannot receive any CVs via e-mail. Please apply via the link below.
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