Head of Clinical Affairs (m/f/d)

in the eHealth Start-Up

Are you interested in experiencing a real start-up spirit and helping to shape the medicine of tomorrow? Then you are welcome!

Medipee GmbH is an innovative company in the field of eHealth monitoring that brings personal health care directly into your own home. We are digitizing a place that is still largely untapped.

For the expansion of our Regulatory Affairs unit, we are looking for a motivated team member who enjoys building our product portfolio.

 

Your tasks:

  • Plan, submit, and monitor clinical trials
  • Review of study data and assurance of specifications
  • Preparation of audits and inspections
  • Preparation of clinical trial reports for regulatory authorities
  • Support in the review of publication drafts
  • Management of external partners and consultants, e.g. CRO, statisticians

 

Your profile:

  • Knowledge of the regulations MDD/IVD, MDR/IVDR, MEDDEV, EN ISO 14155
  • Experience in conducting clinical trials
  • Experience with medical devices
  • a completed degree (Diploma, Master or Bachelor)
  • very good knowledge of MS Office (Word, Excel, Outlook, PowerPoint)
  • Ability to analyze and solve problems
  • flexible, independent and careful way of working
  • Team and communication skills
  • Good command of spoken and written English
  • Reliability, teamwork and hands-on mentality

 

We offer:

  • Independent and self-reliant work in an eHealth team
  • Insight behind the scenes of an eHealth start-up
  • Establishment and expansion of the Regulatory Affairs team with management responsibility
  • Interdisciplinary team with an open feedback culture
  • Flexible working hours
  • Corporate Events/ – Celebrations
  • Opportunities
  • A fair and motivating remuneration system
  • Flat hierarchies and short decision-making paths

 

If you are interested, simply send a CV by e-mail to the contact details given below. We look forward to receiving your application!

 

Contact:

Bianca Bieniek-Witt
Mail: b.bieniek-witt@medipee.com
Phone: +49 2841 6023150