Quality Assurance & Regulatory Affairs Manager

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Who we are:

Doctrin's purpose is to radically improve healthcare globally by helping health care providers to intelligently digitalize the patient journey. We help provide better medical quality, improve patients’ access to care and reduce resource requirements. Two things make us stand out: Our world leading medical history system, and the fact that our system can support the entire patient journey. We are paving the way for a fundamental change in the way healthcare is provided.

Doctrin is growing fast and we need your help to succeed on our journey! 

Who you'll be working with:

You will be working closely with the product development department, but you will actually be touching all departments, as quality processes run through the entire organization. 

How you'll help us radically improve healthcare:

Doctrin is in an expansion phase where you can make a real difference and really impact our future. We are now looking for someone who wants to take on the challenge of leading us towards regulatory excellence and world-class quality while helping us keep our competitive edge of being a fast-moving software company. You will do this by applying your knowledge and experience from quality and regulatory assurance, while working closely with process owners from the entire Doctrin organisation in order to improve our ways of working.

You will:

  • Work in an environment with regulatory requirements within med-tech devices/software and in accordance with relevant regulations & standards (MDD, MDR, FDA, EU, GDPR, CE, ISO, etc.).
  • Own our QMS, which is based on ISO 13485, and use your hands-on knowledge of developing and maintaining a QMS
  • Analyze regulatory requirements in markets that are new to Doctrin, and set business recommendations
  • Be our main contact with authorities concerning registrations, requirements, etc.

In summary, we think you have:

  • 5+ years of experience from working with compliance of medical device software
  • Knowledge in ISO 13485 and IEC 62304
  • An excellent eye for details
  • A strong will to make product development processes run smoothly in the organization, with the purpose to reach world-class quality and efficient processes

It's a plus if you also have:

  • Worked at a tech startup

Why you should apply:

Doctrin is a young and growing company where we all work towards a common goal - to radically improve healthcare. 

You will work with a diversified team of brilliant people, ranging from software developers and medical doctors to ex-management consultants.

We are located in a newly renovated office space in central Stockholm and enjoy doing fun things together - everything from playing table tennis during lunch to meeting up for drinks after work or taking off to an offsite to get to know each other even better. 

We are offering a competitive salary and pension as well as a stock option program. Since we are convinced that healthy employees are a key to success, we offer a generous health benefit.

Do you want to radically improve healthcare together with us? Welcome to apply for the position though the link below.  We look forward to your application!

Questions? Feel free to contact recruiting manager sofia@doctrin.se

 

Location: Stockholm

Form of employment: Full time and permanent

Or, know someone who would be a perfect fit? Let them know!

Stockholm

Sankt Eriksgatan 121D
113 43 Stockholm Directions info@doctrin.se +46 (0)702 54 90 24 View page

Our Culture

In February 2017 we gathered the company in the snowy hills of Tällberg for a 3-day conference. The goal was to discuss what kind of culture and company we wanted to be, as well as to stronger bond as a team. This is a continuous and ever evolving journey but our starting point is our values, which are: 

PASSION FOR MAKING A DIFFERENCE, AIM HIGH, WORK SMART, BE AUTHENTIC, GROW AS A TEAM, ENJOY THE JOURNEY.

Already working at Doctrin?

Let’s recruit together and find your next colleague.

email
@Doctrin.se
  • Anders Fjeldstad
  • Anna-Karin Edstedt Bonamy, MD, PhD
  • Anna Rosenborg
  • Carlos Lorente
  • Clara Franzén
  • Daniel Swensson
  • Dan Iresjö
  • David Bergström
  • Denice Goldschmidt
  • Emil Billberg
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