Senior Regulatory Consultant, SDS MedteQ

Do you have extensive knowledge and experience of regulatory affairs within development of medical device? Would you like a key role in supporting innovative companies with regulatory strategies and hands-on operations? That’s a Senior Consultant at SDS MedteQ!



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. We truly believe in work-life balance, a supportive culture and continuous professional growth. We are proud to be certified a “Great Place to Work”.



As a consultancy, we match your competence to the needs of our clients as much as possible. Here are some examples of assignments we have worked with:



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




Do you want to know more about life at SDS MedteQ and meet the manager? Look at the website created specifically for this position:



https://search4s.teamtailor.com/pages/senior-consultant-sds-medteq



Placement: Stockholm, Uppsala, or Lund. Working partially from a distance is possible

Terms: Full-time or part-time employment with SDS MedteQ as employer

Starting date: As soon as possible or upon agreement





Qualification Requirements:

- Several years of work experience from regulatory affairs within medical device
- Extensive knowledge of and ability to interpret regulations, ISO standards and guidelines for medical device in EU and USA
- Experience from interactions with Competent Authorities and Notified Body.
- Academic degree within science or engineering, or corresponding work experience.
- Excellent spoken and written English.
- Spoken and written Swedish is highly meriting




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 as well as the client. You can 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, yet open to expand and share your knowledge.



Is this you? Welcome with your application!



Application and more information


In this recruitment SDS MedteQ is working with Search4S. For more information contact Recruitment Consultant Anna Rennermalm, +46 707 94 20 05 or anna@search4s.se.



Interviews and selection of candidates will be continuous. Note that the application should be sent through this link and not by email.



Last application date: Nov 21 2021



There is more to say that didn’t fit the ad. Look at the website for this job:

https://search4s.teamtailor.com/pages/senior-consultant-sds-medteq



About SDS MedteQ


SDS MedteQ is a privately owned consulting company which, together with its sister company SDS Life Science, is a leader in the Nordic region in terms of regulatory guidance, quality assurance, design of clinical study programs and development of medical technology products, pharmaceuticals and combination products. The SDS Group is expanding and sales have increased 20-50% annually since the start in 2012. Today, the Group has more than 40 employees and continues to recruit at a rapid pace. In order to continue to recruit the very best consultants, SDS MedteQ works to be an attractive employer and has this year been certified as a "Great Place to Work".



www.sdsmedteq.com (http://www.sdsmedteq.com/)