Specialist, Regulatory Projects (m/f)

Specialist, Regulatory Projects (m/f)

MED-EL ist ein führender Hersteller von innovativen medizinischen Geräten zur Behandlung verschiedener Arten von Hörverlust. Unser breites Produktportfolio bietet Kindern und Erwachsenen in mehr als 100 Ländern eine an ihre spezifischen Bedürfnisse optimal angepasste Hörimplantatlösung. Als international tätiges Unternehmen mit Hauptsitz in Innsbruck beschäftigt MED-EL mehr als 2000 Mitarbeiter weltweit. Zur Unterstützung unseres stetigen Wachstums suchen wir derzeit eine/n:

Specialist, Regulatory Projects (m/f)

Main Tasks

  • Lead, organise and support key regulatory projects / tasks and regulatory compliance initiatives
  • Provide regulatory input to product development projects
  • Support preparation of regulatory submissions, license renewals and registrations to international authorities.
  • Organise and maintain regulatory documentation to meet regulatory requirements

Requirements

  • Higher degree and/or experience preferably in a legal, science or engineering discipline, with a health science or biomedical component e.g. HTA, public health, clinical research, regulatory affairs
  • At least 2 years of experience with medical devices or regulatory affairs and experience of leading and coordinating projects is strongly preferred
  • Experience of regulatory submissions, technical documentation compilation, project management and (EU) 2017/745 Medical Device Regulation is an advantage
  • Excellent English (spoken and written) is required, advanced German strongly preferred
  • Eager to learn, attention to detail & organizational skills, as well as a collaborative personality

Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is EUR 37,559.20.

We offer a challenging opportunity in a multinational work environment with English as our company language. We look forward to receiving your application at jobs.medel.com.