Regulatory Affairs Manager (m/f/d) USA


  • Office: Heidelberg
  • Years of experience: 2-5
  • Schedule: full time


  • HE201_002

We are looking for

  • To strengthen our Regulatory Affairs team we are looking for a Regulatory Affairs Manager (m/f/d) with focus on the USA on a full-time basis.  

Your responsibilities

  • Preparation of the submission dossier according to the requirements of the FDA - Premarket Notification 510(k)
  • Independent implementation of the approval project in cooperation with the US colleagues
  • Renewal of licences in the USA and Canada
  • Collaboration on device approval EU and worldwide as required

Your qualifications

  • Completed technical-scientific training or studies
  • At least 3 years of experience in the approval of medical devices of class IIa / IIb
  • At least 5 successful submissions (510(k)) to the FDA
  • Very good understanding of technically demanding medical devices
  • Experience in ophthalmology is an advantage
  • Experience with OCT is an advantage

Your profile

  • Fluent English and German (written and spoken)
  • Very good organisational and administrative skills
  • Independent and structured way of working
  • Good communication and teamwork skills
  • High sense of responsibility for the tasks and a targeted and precise implementation of the tasks

We offer

  • Interesting, challenging work at a dynamic international company
  • An open business culture and a pleasant working environment
  • Modern workplaces
  • Performance-based compensation
  • A highly motivated team in an international environment
  • An attractive office in Heidelberg's Bahnstadt district, including Job ticket
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