Regulatory Affairs Engineer
Regulatory & Compliance – Stockholm
Join us as a Regulatory Affairs Engineer and be part of the Regulatory & Compliance Department.
Natural Cycles is one of Stockholm's hottest startups and the world's leading startup in the area of contraception and reproductive health. Besides providing women with a life-changing tool to monitor their fertility, the application is also a unique research platform yielding exciting new clinical data on a regular basis.
We are looking for a Regulatory Affairs Engineer experienced from working with quality assurance, compliance issues and working with internal and external audits.
What you will be doing:
- Define product license requirements on different markets
- Handling regulatory submissions and maintain related records
- Represent regulatory affairs in new product development as well as maintenance projects
- Labeling and marketing material review
- Participate in product release process
- Participate in regulatory process improvements work
- Suggest process improvement
What skills and experience you should have
- You are experienced in business development in the MedTech or Pharma industry
- You have experience from working with quality assurance, compliance issue and working with internal and external audits
- You are able to apply your expertise to a big variation of problems and find
- smart solutions within the regulatory and quality area.
- You have excellent English skills, both orally and written
- Your have excellent communication skills
- You are able to work independently.
- You can interpret authority regulations and appreciate compliance work
- You are flexible, analytical and problem solving
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, used to date by more than 800 000 women and we are backed by several international VC firms. Natural Cycles is located in the center of Stockholm, have a great familiar atmosphere and we are a truly diverse workplace with more than 27 nationalities and 60/40 in gender diversity.
Only applications sent through Skills & Talents will be considered.