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Regulatory Project Associate (m / f / d)

MED-ELMünchen, DE

Vor 5 Tagen

Stellenbeschreibung

About 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 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.

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

Your Profile

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 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

Excellent English (spoken and written) is required, advanced German strongly preferred

Eager to learn, attention to detail, proven problem-solving and organisational skills, as well as a collaborative personality

Your Benefits

Central Location

Employee Discounts

Flexible Hours

International Environment

Onboarding

Workplace Well-Being

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.

[email protected]

Please apply in English!