Senior Quality and Regulatory Affairs Specialist

Senior Quality and Regulatory Affairs Specialist


Are you an experienced professional within Quality/Regulatory Affairs who thrives in a dynamic and independent role, where you will have a broad collaboration across the organisation? Then this might be the perfect opportunity for you.

On behalf of our client, a global medical device company, we are looking for an independent and driven professional to be responsible for the quality and regulatory activities in the organisation. Moreover, you will drive exciting cross-functional projects with the aim of developing and sustaining a strong quality culture in the organisation.

Your role

As Senior Quality and Regulatory Affairs Specialist, you will support the Commercial Quality and Regulatory Affairs activities in the Nordics and act as site lead to the management team. Additionally, you will lead Commercial Quality and Regulatory Affairs activities for the company’s Nordic sites (Commercial offices and warehouse/distribution centres), as well as support in the management of third-party suppliers.

Since you will play a key part in establishing quality and regulatory affairs activities in the Nordics, it is essential that you are able to build good working relationships inside the organisation and thrive in a setting with a wide range of stakeholders. Furthermore, you must have an agile mindset as you will oversee both quality and regulatory activities.

Your profile

For this role, we are looking for an experienced professional, ideally with an educational background in Engineering or Life Sciences. You must have a minimum of five years of experience in a Quality role within a medical device Quality/Regulatory setting and a deep understanding of the Medical Device Regulations, EU MDR and ISO 9001. You are a self-starter with great interpersonal skills and able to work independently with minimal supervision.

Fluent in Danish or Swedish and English is required.

Apply now

The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you want to learn more about this position before submitting your application, please do not hesitate to contact Research Consultant, Signe Bülow Hansen on telephone +45 70 20 12 75. Please submit your application and CV as soon as possible, if you are interested. Applications will be processed on an ongoing basis. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.

Deadline: As soon as possible
Workplace: Copenhagen
Reference: 2218.410
Company: Anonymous