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Quality Assurance Specialist

Join the team behind the world's first CE-marked and FDA-cleared software medical device for contraceptive use!

Natural Cycles is the world's leading startup in the area of contraception and reproductive health. We are all about education, scientific research, transparency, innovation and creating an impact. Together with a very passionate team gathered from all corners of the world we work on changing women's lives every single day. 

We are looking for a Quality Assurance Specialist who is passionate about compliance and contributing to establish an internal culture of improvement and Quality Management System (QMS) involvement!

What we are doing

Our Regulatory & Compliance team focus on efficiency and simplicity, creating internal structures that give value to the different departments and the way of working. So far this has resulted in Natural Cycles being the first CE-marked app for contraceptive use and the first software medical device to be cleared for contraceptive use by the FDA, as well as having a successful track record with audits. We are indeed pioneering women's health and regulatory with our innovative product and committed team!

What you will be doing

You will be working on the QMS structure and its continued compliance including gap analysis towards new or updated regulatory requirements, as well as lead interpretation and implementation activities. You will support the organisation to adapt the QMS with continued growth of the organisation.

The role also includes support of QMS improvements and identifying and implementing necessary interfaces between different departments and sites. You will work with Quality functions and tasks within the QMS, including updating the Quality Manual and owning the Document Control process.

Examples of responsibilities

  • Lead the completion and maintenance of risk analysis related to quality systems
  • Perform internal and and participate in external audits
  • Support investigations, and resolve Quality System non-conformities (defined during internal and/or external audits)
  • Responsible for that Quality Agreements are kept up to date
  • Work with all departments in order to make sure the way of working are reflected in the QMS when applicable
  • Advice on compliance across all aspects of applicable regulations 
  • Give necessary training internally regarding the QMS

What skills and experience you should have

  • Experience of a strictly regulated business environment is essential (e.g. Regulatory affairs, Medical Device, Clinical, Medical, Pharmaceutical)
  • Experience in software business is preferred
  • Experience in Medical Device Directive 93/42/EEC and MDR is preferred
  • Experience in ISO 13485, QSR and ISO 14971 is essential
  • Successful experience in redesigning and implementing a QMS in a global organisation
  • Demonstrated understanding of business need versus compliance
  • Good project management skills
  • Excellent English, verbal and written

How to apply

Apply by simply clicking on the button below, connect your LinkedIn-profile to your application and answer the questions in the application form. No CV or cover letter needed!  We know that diverse teams are strong teams, so we welcome those from different backgrounds and experiences.  Please note that only applications in English and submitted through the career site will be considered. 

About Natural Cycles

Natural Cycles is a revolutionary approach to birth control and family planning, empowering women to take informed decisions. Developed initially by two former physicists, our algorithm and app is clinically tested and backed by several international VC firms. Together with a very passionate team gathered from all corners of the world we work from our international offices on changing women's lives every single day. We have a great familiar atmosphere and a truly diverse workplace with more than 20 nationalities and 70/30 in gender diversity.

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Stockholm

Luntmakargatan 26
11137 Stockholm Directions info@naturalcycles.com

Life at Natural Cycles

Being a passionate and committed team we  spend a lot of time working together, but we also make sure to have fun! We celebrate every success and milestone together as a team, and enjoy spending time together at our weekly fika, monthly after works, and other fun events such as board game nights, yoga classes and workouts.

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