Compliance Officer

Malmö, Sweden

We want to make quality healthcare accessible to everyone from anywhere, easily and with empathy. A new type of healthcare that's in harmony with your daily life.

Healthcare that's better for you, better for healthcare professionals and, of course, better for society.

Want to join the Docly healthcare revolution? We're looking for a Compliance Officer who shares our passion. If that's you, we'd love to hear from you!

What you will do

You will work hands on, primarily in the areas of med-tech and health care compliance to ensure regulatory compliance. Naturally, you will also be involved in other related legal areas. Docly is currently in the transformation process from MDD to MDR, meaning that we are reviewing and improving our processes to make sure they are complaint with the new regulations. You will take lead and drive the establishment, implementation and continuous improvements of the new Docly Management System, including our Quality Management System (QMS), the Technical file, certification processes, and more.

You will do this by working cross functionally, in close collaboration with all of your Docly colleagues, in particularly the product development team. You will be part of our Legal and Compliance team reporting to our Head of Legal and Compliance.

We are an agile software company offering a new and exciting role in a growing organization where your effort can really make a difference!

These will be your primary work assignments:

  • You will acquire and maintain knowledge about applicable legislation and regulations concerning healthcare delivery and medical devices in the relevant geographies (currently Sweden and UK).
  • You will ensure compliance to MDR and other relevant legislation.
  • You will be our person responsible for regulatory compliance (PRRC) as defined in MDR. This implies you will be responsible for ensuring that:
    • The conformity of our product is appropriately checked, in accordance the QMS under which the product is manufactured, before it is released
    • The technical documentation and the EU declaration of conformity are drawn up and kept up to date.
    • The post-market surveillance obligations are complied with in accordance with the requirement of the MDR
    • Reporting obligations are fulfilled
  • You will manage and continuously improve our Management System, including our QMS.
  • You will set up and manage our internal audit function.
  • You will be our key contact to the Notified Body, regulatory authorities, etc.
  • You will liase with our UK based compliance team to ensure we have an overarching and adequate compliance program.
  • You will participate in the risk analysis work we do.
  • You will provide training as well as continuous legal and regulatory support and advice to your colleagues within your area of expertise.
Who are you?

We expect you to have the following qualifications and experience:

  • You have a university degree in law and the required expertise in the field of medical devices, in order to take on the role as responsible person for regulatory compliance (PRRC) in accordance with the MDR directive.
  • You have worked in an environment with regulatory requirements within med-tech devices/software and in accordance with relevant regulations & standards (MDD,MDR, EU, CE, ISO, etc.).
  • You have a holistic view of QMS, as well as hands on knowledge of developing and maintaining a QMS.
  • You have experience from working close to product development in general and software development specifically.
  • You have experience of working, both technically and commercially, with quality assurance and regulatory compliance.
  • You have participated in risk analysis work.
  • You are able to act independently, but also collaborate effectively internally as well as externally.
  • You have an organized, structured, accurate, independent and pro-active way of working.
  • You have strong analytical and project management skills combined with a communicative ability and being detail oriented.
  • You take responsibility for your actions.
  • You are fluent in both spoken and written Swedish and English.
How to apply

Please send your CV and cover letter no later than January 17, 2020 to mailto:christina.hedman@docly.com. If you have any questions please contact Diana Melander, Head of Legal and Compliance, at mailto:diana.melander@docly.com for more details.

Looking forward to hear from you!

About Docly

Docly was founded as ‘Min Doktor‘; in Sweden in 2013 and was the country's first digital healthcare service. We're now seen as the industry's gold standard and have taken care of over 500,000 people and counting. As well as Sweden, Docly now puts healthcare in the hands of people in the UK.

Docly's ‘Time To Care’ concept streamlines the work of healthcare professionals offering structured data collection, analysis and quality improvement, enabling them to focus on caring for more patients quickly and efficiently. Digital consultations such as Docly's text-based model are now an essential element of healthcare's digital age. It's time to care.

At Docly we pride ourselves on our commitment to the highest level of quality, innovation and security. We comply with each European country's laws and regulations governing healthcare providers and all data is collected, stored and transmitted in secure, encrypted form in accordance with EU law and GDPR.

Who are we

We are around 60 passionate people, ranging from healthcare professionals to engineers, designers and business developers working closely together, challenging ourselves in what we do and how to do it.

We share a strong sense of purpose and we believe in that we are making a difference in people's everyday life through our healthcare service. And we truly believe that our diversity is a great asset for both the company and our patients. The opportunities to grow and learn from knowledgeable colleagues are endless.

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Is your dream position missing?

We are always in search of talented people!

If you have skills that you think would contribute to our service, then we'd love to get to know you. Send your open application in English to recruitment@docly.com

We comply with the General Data Protection Regulation and our policy regarding personal data during recruitment. Please see the aforementioned policy for more information, or contact our DPO at dpo@docly.com

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