What we do
SDS MedteQ offers high-class support in developing medical technology products and combination products. Our services include regulatory advice, product classification, quality assurance, setting up quality systems, producing technical documentation, risk management, biological evaluations, development of synopsis for clinical studies, sponsor oversight for clinical studies, project management, and the person responsible for regulatory compliance.
Desirable qualifications
- An academic degree in the natural sciences or technical field. Alternatively, equivalent education/work experience.
- Broad knowledge in medical technology development (regulatory issues, clinical studies, CE marking/FDA approval)
- At least ten years of work experience with good knowledge of classification, technical documentation and review processes according to regulations/ISO standards/guidelines
- Experience in communication with notified bodies/FDA
- Professional level of spoken and written English.
- Other information about the service
We are looking for knowledgeable and experienced employees who are passionate about developing medical technology products and who find it easy to collaborate. Personality is important both to be able to meet our customers, and to contribute to the further development of the company and the organization.
Application
Send your CV and cover letter to Johan Sköld at johan.skold@sdsmedteq.com.
Be clear about what kind of job you are looking for in the cover letter.
About SDS MedteQ
SDS MedteQ is a Swedish company founded in 2020, and since 2022 part of Cytel Inc. SDS MedteQ supplies medical technology companies with consultancy services in regulatory affairs, clinical development, quality assurance and compliance project management. The clients are mainly Nordic small-medium enterprises but also big pharma. With its sister company SDS Life Science, which focuses on pharmaceutical development and statistics, SDS has over 60 employees and a Ph.D. rate of over 50%. In 2021, the SDS Group ranked as Sweden’s 11th best employer in the category of small enterprises, according to Great Place to Work. The Managing Director of SDS MedteQ is Anna-Karin Alm.
