mySugr GmbH
Regulatory Affairs Manager Freelancer(m/w/x)
Part-timeFreelanceOn-siteSenior
Wien
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MYmySugr GmbH
Regulatory Affairs Manager Freelancer(m/w/x)
Wien
Part-timeFreelanceOn-siteSenior
Nejo AI Summary
Regulatory compliance for Class IIa/IIb medical devices at a firm focused on early diagnosis, maintaining ISO13485, MDR, MDSAP certifications. Experience with EU/FDA regulations and ISO quality management standards required. Flexible modern workplace.
Requirements
- Experience with EU or FDA regulations
- Experience with ISO quality management standards
- Experience with medical device registrations
- Experience in regulatory authority audits
- Multitasking and organizational skills
- Experience optimizing cross-jurisdictional processes
- Excellent English communication skills
- Willingness to learn
- Willingness to work in fast-paced corporations
- Knowledge of the diabetes industry
- Technical understanding of innovative software
- Experience in agile environments
Tasks
- Support product development activities
- Ensure continuous regulatory compliance
- Maintain lean and effective regulatory processes
- Manage class IIa and IIb medical device products
- Uphold ISO13485, MDR, and MDSAP certifications
- Expand regulatory frameworks into new product fields
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- EU Medical Device regulations
- FDA Medical Device regulations
- ISO standards
- 510k Medical Device registrations
Benefits
Other Benefits
- Healthy, equal and inclusive environment
Family Support
- Family friendly career paths
Sustainability Focus
- Sustainability
Healthcare & Fitness
- Healthy lifestyle
Modern Office
- Flexible modern workplace
Learning & Development
- Culture of learning and sharing
- Professional and personal growth opportunities
Informal Culture
- Open and candid feedback
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of mySugr GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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MYmySugr GmbH
Regulatory Affairs Manager Freelancer(m/w/x)
Wien
Part-timeFreelanceOn-siteSenior
Nejo AI Summary
Regulatory compliance for Class IIa/IIb medical devices at a firm focused on early diagnosis, maintaining ISO13485, MDR, MDSAP certifications. Experience with EU/FDA regulations and ISO quality management standards required. Flexible modern workplace.
Requirements
- Experience with EU or FDA regulations
- Experience with ISO quality management standards
- Experience with medical device registrations
- Experience in regulatory authority audits
- Multitasking and organizational skills
- Experience optimizing cross-jurisdictional processes
- Excellent English communication skills
- Willingness to learn
- Willingness to work in fast-paced corporations
- Knowledge of the diabetes industry
- Technical understanding of innovative software
- Experience in agile environments
Tasks
- Support product development activities
- Ensure continuous regulatory compliance
- Maintain lean and effective regulatory processes
- Manage class IIa and IIb medical device products
- Uphold ISO13485, MDR, and MDSAP certifications
- Expand regulatory frameworks into new product fields
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- EU Medical Device regulations
- FDA Medical Device regulations
- ISO standards
- 510k Medical Device registrations
Benefits
Other Benefits
- Healthy, equal and inclusive environment
Family Support
- Family friendly career paths
Sustainability Focus
- Sustainability
Healthcare & Fitness
- Healthy lifestyle
Modern Office
- Flexible modern workplace
Learning & Development
- Culture of learning and sharing
- Professional and personal growth opportunities
Informal Culture
- Open and candid feedback
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of mySugr GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
mySugr GmbH
Industry
Healthcare
Description
The company is committed to transforming healthcare through sustainable action and innovation, focusing on early diagnosis and targeted treatments.
Not a perfect match?
- mySugr GmbH
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Compliance Expert(m/w/x)
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Freelancer Embedded Software Engineer(m/w/x)
Part-timeFreelanceOn-siteExperiencedZeltweg, Wien