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SDS MedteQ is a privately owned consultancy company. Together with our sister company, SDS Life Science, we are a leading Nordic company supporting clients with regulatory guidance, quality assurance, design of clinical study programs and development of medical device, pharmaceuticals, and combination products. 

There is a seemingly endless need for consultancy services within regulatory affairs and quality of medical device of all classes & development stages. New regulations and a local market with mainly small and medium-sized enterprises calls for experts that can add guidance and support. We help bringing new, life improving, products to the market. 

Right now, we are looking for a senior specialist in regulatory affairs within medical device. 

Qualification requirements

You need to have enough knowledge about the regulatory requirements to be able to help others with the CE-labelling process. We think that you have worked several years within some class of medical device with e.g. interpreting regulations, ISO-standards and guidelines. You are also familiar with Notified Body and Competent Authority processes. 

As Senior Consultant we expect you to be able to work independently, but always in close collaboration and communication with the team at SDS MedteQ and the clients. You put regulatory and quality in a business perspective and suggest strategies that drives projects forward in a timely and cost-effective manner.  You are confident in your expertise, open to expand and share your knowledge.

SDS MedteQ is built by the people working here. As most specialists we value professional development and making positive change through technical and scientific expertise. You will have independent responsibilities, yet there will always be a colleauge who is up to date and ready to back you up. 

As a Senior Consultant you work with clients that need your specific skills in the development or upkeep of medical device. For many assignments you have to learn something new, going slightly outside your comfort zone. Other times, it will be more peaceful routine work. The mix of projects, products and types of clients is one of the benefits of being a Consultant. 

We believe in a supportive culture and continuous professional growth. We are proud to be certified a “Great Place to Work”.

We have normal working hours, 6 weeks vacation, and offer all that is required of a safe and sound work place. Life is more than work. Everyone at SDS can ask for reduced working hours, temporarily or permanently.  

Physical and mental health is key to a happy work life. We offer the maximum wellness allowance (friskvårdsbidrag) and make sure to support each other through thick and thin. 

As a consultancy, we match the needs of our clients with the right consultant. What you will do is therefore highly dependent on your own competence. As Senior Regulatory Consultant, assignments might be: 

• Classification of novel products. Is it a medical device? What class? A combination product or something else?
• Creating feasible regulatory strategies from early development stages to commercialization.
• Selecting and managing contact with Notified Bodies 
• Communication with Competent Authorities, mainly EU and FDA, and interpretation of regulations, standards & guidelines.