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 an 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