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mySugr GmbH
6d ago

Regulatory Affairs Manager Freelancer(m/w/x)

Wien
Part-timeFreelanceOn-siteSenior

Description

You will ensure the company's innovative medical apps remain compliant by managing lean regulatory processes for class IIa and IIb products while supporting fast-paced development cycles.

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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

Work Experience

5 years

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

Tools & Technologies

EU Medical Device regulationsFDA Medical Device regulationsISO standards510k Medical Device registrations

Languages

English – Business Fluent

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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