Job Summary

You will be the first Compliance & Quality Manager joining our new cross-functional team who will further lead and drive the implementation of our QMS and risk processes. You will be the key driver in growing a strong Compliance & Regulatory culture in the different teams and amongst the whole organisation.

Responsibilities

  • Perform, orchestrate and execute all CE certification processes according to MDR
  • Implement, monitor and evaluate our QMS and Risk Management
  • Ensure compliance to international standards and applicable regulations through regular audits and proactive training
  • Lead BfArM related admission activities regarding Digital Supply Law and its 
  • Assist and advise product, engineering, research and business developing through all strategic regulatory and compliance questions
  • Keep up to date with regulatory changes and built out your network within the (digital) health care community

Skills/Requirements

  • 1-2 years of related experience in Compliance & Regulation in health care
  • 3-5 years of work experience
  • Extensive track record in developing, implementing and monitoring medical device certification processes (according to MDD/MDR)
  • Advanced knowledge of project management, tools, templates and (agile) methodologies
  • Proficient knowledge in developing and leading risk management activities
  • Ability to communicate, teach and mediate effectively across functions with different levels of regulatory understanding
  • Ability and inner drive to do in-depth research and to interpret written guidelines and documents.

Nice to have:

  • You have worked in Compliance & Regulations in digital health care companies and are familiar with modern software development
  • Experience in GDPR
  • Fluent in German will be considered a advantage

Benefits

  • Amazing roof-top office in the center of Berlin close to Hackescher Markt with ergonomic chairs and fantastic atmosphere
  • Flexible working hours and home-office friendly. We are a delivery-oriented company and don’t judge people by the hour
  • Attractive Relocation Package
  • Competitive salary and attractive employee stock option plan
  • Unlimited working contract
  • Various opportunities for growth with your own 1.000 Euro annual training budget
  • Daily breakfast, fresh fruits & vegetables, coffee & drinks provided
  • Subsidised Gym subscription with Urban Sports Club - 30 Euros sponsored by us
  • Free language courses and regular team events including cool offsites
  • Tax deductible pension plan with an attractive employer’s contribution
  • Free choice between Apple (e.g. Macbook Pro 13/15”) or Windows/Linux Hardware (e.g. Lenovo ThinkPad T490s, 14", Core i7, 16GB RAM, 512GB SSD)


Company

Founded in 2015 by internationally recognized experts in the field of e-mental health, GET.ON is now one of the leading providers of online health training in German-speaking countries


Industry

Healthcare

Company Type

Private

Official website

https://geton-institut.de/

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