Quality Assurance Specialist

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 dedicated Quality Assurance Specialist who wants to work in a small and well integrated team, having full insight in all aspects of the company's regulatory and compliance work. In this role you will be able to expand your knowledge and experience in all areas related to the compliance of software as a medical device on a global market.

The position will either be based in Stockholm or remote in the European or EST time zones.

What we are doing

Our Regulatory & Compliance team focuses 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 very 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 leading implementation activities. You will support the organisation to adapt the QMS to the continued growth of the organisation. The role also includes support of QMS improvements and identifying and implementing necessary interfaces between different departments and sites. The regulatory team works closely with the development team and we therefore think that you are interested in and motivated to work in a technical environment.

Examples of specific tasks:

Maintaining the Document Control process.
Maintaining the risk analysis related to the QMS
Participate in internal and and external regulatory audits
Support investigations and resolve QMS non-conformities
Responsible for Supplier management
Provide support and training to other departments in relation to your responsibilities


What skills and experience you should have

Experience from a strictly regulated business environment (e.g. Regulatory affairs, Medical Device, Clinical, Medical, Pharmaceutical)
Experience in ISO 13485 and ISO 14971
Demonstrated understanding of business need versus compliance
Good project management skills
Excellent English, verbal and written, as English is the language of the organisation in general and regulatory communication in particular.


Not required but it would be great if you also have

Experience with CFR 21
Experience from a software business or software as a medical device
Experience working with the EU Medical Device Regulation
Experience in IEC 62304 and IEC 82304
At least 1 year of work experience from a similar or related position


How to apply

Simply click on the button below and on "Apply with LinkedIn" to connect your LinkedIn-profile to the application directly. Then all you have to do is to answer the questions in the application form - no CV or cover letter needed! Please note that only applications in English and submitted through the career site will be considered.

We know that diverse teams are strong teams, so we welcome those from different backgrounds and experiences. To help us place the right people in the right role, we believe in science-based and fair assessment methods. Therefore, as part of our recruitment process, we use Alva Labs assessments to help us increase our hiring success by identifying the candidates that are most likely to thrive and be successful in the role.

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.