Regulatory affairs specialist
Natural Cycles / Logistikjobb / Stockholm
2017-05-18
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hela Sverige Visa alla jobb hos Natural Cycles i Stockholm Natural Cycles provides women the effective and easy-to-use fertility app - a revolutionary approach to family planning and women's health. We are on a mission to educate and empower women to take control of their fertility and future, championing a vision where every pregnancy worldwide is wanted.
We are now looking for a Regulatory Affairs Specialist with a passion and an interest for the regulatory field. You will be involved in maintaining and improving our internal quality processes to ensure that the company remains compliant for upcoming audits. This will be a challenging task, as the regulatory field for Health is at an early stage, as there are new upcoming regulatory requirements and as the company is growing quickly!
You will have the opportunity to work closely with management and other team members to get expert knowledge on the internal processes and contribute to our market expansions.
We are looking for someone to start as soon as possible to fill in for a 8 month parental leave, but if you perform well and you remain passionate about working for Natural Cycles, you are likely to be able to continue with us. At Natural Cycles you have the chance to be part of an exciting journey with an ambitious mission!
Your tasks:
Develop a deep understanding of the medical device regulatory field for mobile apps and contraception.
Maintain and improve the current quality management system and technical file together with the relevant departments.
Implement the new requirements from the ISO 13485:2016 standard on Quality management systems.
Analyse the newly approved european Medical Device Regulation for new applicable requirements and set up an implementation plan.
Educate employees on regulatory requirements and changing processes.
Contribute to ongoing regulatory & clinical affairs performed at Natural Cycles
Your skills:
Education: BSc or MSc degree required, within the fields of Science, Life Science or Business
Ability to maintain confidentiality of information and materials
Ability to work independently and structured to identify and filter through a large volume of information to solve the problem at hand
Fluent in both written and spoken English
Varaktighet, arbetstid
Heltid Anställningstid enligt överenskommelse
Publiceringsdatum2017-05-18Ersättning Lön enligt överenskommelse
Så ansöker duSista dag att ansöka är 2017-11-04
Klicka på denna länk för att göra din ansökanKontaktMikael Berglund
mikael@naturalcycles.com 070 172 92 53
FöretagNatural Cycles
AdressNatural Cycles
Luntmakargatan 26
11137 Stockholm
KontorsadressLuntmakargatan 26, Stockholm
Jobbnummer 3508119
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