Regulatory Affairs Manager:in (m/f/d) - digital medical devices

Experience the future of digital medicine at first hand! Our SaniQ platform is the modern therapy basis for doctors and patients with chronic diseases. It is an indispensable component of numerous care projects. With your work with us, you are actively shaping the future of medicine and making a valuable contribution to improving healthcare.

Be part of a highly motivated team that supports you every step of the way and offers you numerous creative opportunities. Realise your visions and make a big difference!

  • Your main task is to ensure compliance with regulatory requirements for new developments as well as for the maintenance of existing approvals related to digital health services.
  • Your cooperation is needed in the planning, organisation and coordination of product approvals.
  • You create and maintain approval-relevant technical documentation.
  • You act as a contact person for legal issues (SGB V).
  • You will be responsible for communicating with health insurance companies and law firms as well as other stakeholders in the health care system.
  • Natural science, technical, legal studies or comparable qualification
  • Prior knowledge in the field of medical device law, MDR is an advantage, but the willingness to familiarise oneself with this subject area is a prerequisite.
  • Initial experience in the field of regulatory affairs for medical devices and in dealing with standards and laws desirable
  • Confident handling of MS Office
  • Independent, careful and goal-oriented way of working
  • Very good written and spoken German
  • Good command of written and spoken English
  • The ability to work in a team and enthusiasm for our applications round off your profile.

We live not only work, but a common vision: revolutionise digital medicine and make the world a little bit better every day. Our enthusiasm is contagious and we work passionately as a team to achieve our goals. Our focus is not only on the short-term result, but on long-term growth for every single team member.

Welcome to the future of work! We are pioneers in the area of New Work and offer you an agile working environment with state-of-the-art equipment and trust-based working hours as well as home office. Trust, cohesion and honesty prevail at our company - flat hierarchies and an open exchange at all times included.

For us, the team is the focus! We want every employee to feel valued and comfortable at all times. That's why we offer you numerous benefits, such as corporate benefits, bicycle leasing and an e-pool vehicle for your use. You get free water, coffee and soft drinks, and muesli, soups, a candy bar and fresh fruit provide the power kick in between.

Are you ready to become part of our great team and change the world together with us? Then apply now and shape the future of SaniQ with us!

Location: Koblenz

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