Regulatory Affairs Specialist (m/f/d)

Einsatzort: Innsbruck

Logo MED-EL

Carreer at MED-EL
MED-EL is a leading manufacturer of innovative medical devices for the treatment of various types and degrees of hearing loss. Our unique portfolio of implantable hearing solutions benefits thousands of individuals in more than 100 countries worldwide. With headquarters in Innsbruck, Austria, MED-EL has over 2000 employees around the world. In support of our continuing growth, we currently have an open position with focus on:

Regulatory Affairs Specialist (m/f)

RA_1_1907

Innsbruck, Austria

Main Tasks

  • Lead, organize and support submissions to Notified Body
  • Support preparation of regulatory submissions, licence renewals and registrations to international authorities
  • Organize and maintain regulatory documentation and data files to meet regulatory requirements
  • Provide regulatory input to product development, product changes and manufacturing changes

Requirements

  • Master's degree is required, 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 medical device or regulatory affairs work experience is strongly preferred, graduates with any biomedical related experience e.g. in pharma industries, clinical research or health technology assessment are also welcome
  • Excellent English (spoken and written) is required, German native speaker or excellent German
  • Eager to learn, attention to detail, proven problem solving & organizing 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 36,154.72

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

MED-EL Medical Electronics

Headquarters
Fürstenweg 77a
6020 Innsbruck, Austria
Tel +43 (0) 5 7788 7788
jobs.medel.com