Regulatory and Compliance Specialist
NaturalCycles Nordic AB / Säkerhetsjobb / Stockholm
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hela Sverige Visa alla jobb hos NaturalCycles Nordic AB i Stockholm Natural Cycles is an international working environment filled with smart and ambitious colleagues working in Stockholm, Geneva, New York and remotely. Our mission is to pioneer women's health with research and passion - by empowering everyone with a menstrual cycle with the knowledge they need to be in charge of their health.
What you will be doing:
As a Regulatory and Compliance Specialist you will be supporting the company and the regulatory team with documentation, filing, investigations, analysis, improvements and development within the quality, compliance and regulatory space. You will be working in a stable but innovative QMS which is small enough for you to be able to be involved in all relevant processes. You will acquire valuable knowledge and experience which will prepare you for a successful career within NaturalCycles and in the medical device regulatory industry.RegulatoryAssist in implementing regulatory strategies
Regulatory:
• Assist in implementing regulatory strategies
• Assisting or managing regulatory submissions and maintaining related records
• Assisting or managing regulatory reporting
• Assisting or managing regulatory reporting
Compliance (Quality):
• Develop QMS compliance with applicable regulations & standards (ISO13485, MDR, QSR)
• Work with supplier evaluations and associated risk analysis
• Improve and maintain processes and work instructions, working together with all functions within the company
• Assist in certification, surveillance, internal & unannounced audits
• Suggest and implement process improvements
• Promote the QMS and its principles throughout the organization
Every employee at Natural Cycles shall contribute to maintain and improve the quality system in order to comply with all applicable regulations and standards, especially with ISO 13485
What skills and experience we think you have
Required:
• University degree in science/technical or equivalent (5 years)
• Excellent English skills, both orally and written
• Excellent communication skills
• Ability to understand and explore medical device regulations and identify innovative process solutions
• 1-3 years experience within the regulatory framework of medical devices
Nice to have:
• A degree and/or interest in biomedical engineering or similar
• Experience with standards such as ISO 13485, ISO 14971, IEC 62304, IEC 62366 etc.
• Experience with regulatory legislation such as 21 CFR, EU MDR and similar
How to apply
Apply by uploading your CV and answering the questions in the application form. Please note that we do not accept any applications through email due to GDPR and only applications submitted through the career site (and in English) will be considered.
We know that diverse teams are strong teams, so we welcome those from different backgrounds and experiences and are committed committed to creating an inclusive environment for all employees and candidates.
Ersättning Lön enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2023-08-26
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Naturalcycles Nordic AB (org.nr 556952-7657),
http://www.naturalcycles.com Arbetsplats Natural Cycles
Jobbnummer 7528314
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