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Quality Assurance & Regulatory Affairs Manager

Quality Assurance & Regulatory Affairs Manager

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:

Our teams are cross-functional with a mix of developers, medical doctors, QA, data scientists, UX, product managers and customer support.

How you'll help us radically improve healthcare:

Imagine if what you did could directly improve healthcare for 1 billion people? That’s what we want!

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 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.

What you'll do:

First off, we believe that you want to radically improve healthcare just like the rest of us at Doctrin!

At Doctrin, we are now in the transformation process from MDD to MDR, meaning that we currently are reworking and improving our processes for the new regulations. You will take lead and drive the direction of the new Doctrin QA/RA function, and you will also be working hands on with all the details that need to be in place. Among other things, you will be responsible for our regulatory compliance in general, our QMS, the Technical file, certification processes, and more. Of course, you will do this in close collaboration with your Doctrin colleagues, and you will be part of the Product organisation within the company.

Our core values, Passion for making a difference, Aim high, Work smart, Be authentic, Grow as a team and Enjoy the journey, rule the way we do things and it´s important that you believe that your personal values correspond with ours.

We expect you to be excited about building our brand-new QA/RA function, and you look forward to the challenge of doing this in a way that is needed in an agile software company.

Examples of work assignments and qualifications that you may have experience in can be seen in the list below. If you feel that you match one or more of them, do not hesitate to contact us! 

  • 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.).
  • Possesses the requisite expertise in the field of medical devices, in order to take on the role as responsible person for regulatory compliance in accordance with the MDR directive.
  • Experience from product development in general and software development methodologies specifically.
  • Have a holistic view of QMS, as well as hands on knowledge of developing and maintaining a QMS.
  • Experience of working, both technically and commercially, with quality assurance and regulatory compliance.
  • Lead and participate in risk analysis.

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 frederik@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

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
  • Anna Rosenborg
  • Carl-Fredrik Grimberg
  • Carlos Lorente
  • Clara Franzén
  • Daniel Swensson
  • Dan Iresjö
  • David Bergström
  • Emil Billberg
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