Regulatory Project Associate (m / f / d)

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 140 countries worldwide. With headquarters in Innsbruck, Austria, MED-EL has over 2,800 employees around the world.

Your Tasks

Our Regulatory Affairs department ensures that products comply with applicable regulations and standards. This includes providing strategic input to product developments, obtaining and maintaining product registrations and approvals, communicating with authorities, and monitoring regulatory changes to ensure continued compliance.

1. Lead, organise and support key regulatory projects / tasks and regulatory compliance initiatives.
2. Organise and support preparation of regulatory submissions, licence renewals, registrations and change notifications to international authorities.
3. Organise and maintain regulatory documentation to meet regulatory requirements.
4. Provide regulatory intel to product development projects.

Your Profile

1. 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.
2. At least 2 years medical device or regulatory affairs work experience is strongly preferred; graduates with any biomedical related experience e.g. in pharmaceutical industries, clinical research or health technology assessment are also welcome.
3. Excellent English (spoken and written) is required; advanced German is strongly preferred.
4. Eager to learn, attention to detail, proven problem-solving and organisational skills, as well as a collaborative personality.

Benefits

1. Central Location
2. Employee Discounts
3. Flexible Hours
4. International Environment
5. Onboarding

Interested?

Want to join a company that helps bring the joy of sound to people with hearing loss? Apply now!

Your Contact Person

If you have any questions please contact Caroline Schenk.