Product Compliance Specialist

Kry is a digital healthcare service enabling patients to meet and seek advice from healthcare professionals online. We’re on a mission to build better and more accessible healthcare by providing digital and seamless digi-physical services that gives patients the best possible health care experience, regardless of location.

What you´ll be doing

  • Supporting the business in all regulatory affairs activities, including MDR implementation, audits, complaints, maintenance of regulatory files, liaison for external contact with authorities and ethics boards (investigational device trials), etc.
  • Be part of a small team focusing on compliance, working closely together with legal, security, market-specific quality, and compliance teams,  R&D, and other stakeholders
  • Write lightweight and easy to understand policies, procedures, and programs, with support from others when necessary
  • Drive the implementation of these policies and procedures to our agile and fast-growing organization. 
  • Advocate and communicate the importance of product compliance to the KRY/LIVI group, and train personnel on relevant policies, standards, and processes
  • Own planning, work tracking, and execution of implementing new frameworks in new markets, such as making sure requirements are integrated into the Kry/Livi way and nothing falls between the cracks.
  • Perform internal quality assurance and follow up on implemented policies to make sure they work efficiently

Who you are:

  • You have expertise within Regulatory affairs with knowledge of Quality Assurance (QMS maintenance, audits, supplier evaluation) and Medical Devices across global markets.
  • At least 3-5 years of working experience within an agile RnD organisation, government authority, notified body or corresponding where you worked with quality assurance, regulatory affairs or the development of medical device software.
  • You are familiar with standards such as ISO 13485, ISO 9001, ISO 14002, IEC 62366, IEC 62304 and share our belief that it is the essence of standards that is important. You are eager to find new ways of implementing that essence enabling the business to balance the need for speed and patient trust, in a highly regulated environment.
  • You have a strong sense of ethics and principles but have a pragmatic and in-it-for-the-long-game work attitude where proactive, thorough and a willingness to keep learning are leading words.
  • You have experience working with a diverse set of stakeholders to figure out reasonable ways forward
  • You like reading AND writing, finding a thrill in converting complex regulatory standards into understandable frameworks for those not as passionate about regulatory affairs as we/you are.
  • You have good enough legal understanding such that working together with a legal team is second nature to you.

What’s in it for you?

  • Amazing, friendly, smart colleagues from all over the world
  • The opportunity to grow and learn from knowledgeable co-workers and cross-collaboration across departments
  • As a team, committing to goals, sharing both success and failures
  • The chance to be a part of the journey of building the future of healthcare
  • Relocation package, including work permit administration, mobility support (including finding accommodation), contribution to Swedish lessons and we will make sure to show you the best of Stockholm
  • We promote and encourage a healthy lifestyle with yoga, meditation and gym in the office, wellness reimbursement, many employee sports and fun activities such as running and football groups, healthy snacks, and a beautiful office in the city of Stockholm
  • Be part of an amazing journey at a company that invents the future of healthcare

 

This is your chance to work for a meaningful company that encourages personal development and celebrates diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, or marital status.

 

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We offer a unique opportunity to gain a broad and deep understanding of the inner working at Europe’s leading digital healthcare provider. We value grit and a can-do attitude; there is a long and challenging journey ahead of us. You are brave enough to set high goals and then work passionately to achieve them. Last, but not least, we think you believe in that by working together we will achieve greater things than by working alone. At Kry we care about each other and the world around us. Expect to have fun and learn new things every day!

Please submit your application by including your CV, LinkedIn, GitHub or Portfolio.

If you have any questions regarding jobs or our recruitment process, please read our FAQ or contact us on jobs@kry.se. Please note that we do not accept any email applications due to GDPR.  

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

Kry

We’re on a mission to build better and more accessible healthcare

 

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