Stellenzeigen Regulatory Affairs Specialist MDT_DF

UL MDT hat sich auf Prüfungen rund um das Thema Medizinprodukte spezialisiert. Wir bieten einerseits Full-Service
CRO-Dienstleistungen im Bereich klinischer Prüfungen mit Medizinprodukten, Kombiprodukten und In-VitroDiagnostika an. Andererseits gehört zu unserem Portfolio auch ein umfassendes Spektrum an Leistungen für
präklinische Produktprüfungen, für die wir nach EN ISO 17025 akkreditiert und GLP zertifiziert sind. Seit 2011
gehören wir zum weltweit agierenden Konzern Underwriters Laboratories (UL).
For our CRO Team at Ochsenhausen we are recently looking for a
Specialist Regulatory Affairs Medical Devices (m/f)
Your tasks:
• Clarification of project-related regulatory requirements
• Assessment and compilation of submission documents for clinical investigations with medical devices at
competent authorities and ethics committees
• Coordination and preparation of Scientific Advice Meetings at competent authorities
• Coordination and communication between authority / ethics committee and sponsor
• Preparation and handling of trial submission approval / evaluation of clinical tests at the responsible
higher federal authority or ethics
• Conception and performance of customer coachings and trainings on regulatory topics
• Check with regulatory requirements regarding incidence reporting and follow up with responsible
parties
Your profile:
• Experience in the field of clinical testing of medical devices class I to III (focus on III)
• Knowledge of regulatory requirements for clinical testing for medical devices for CE certification, FDA
approval, PMCFs
• Experience in dealing with ethics committees, authorities and notified bodies
• Comprehensive knowledge in relevant standards (ISO 14155 GCP/ ISO 14971, ISO 13485) and the
legislation (MPG, AMG), GCP (good clinical practice), ICH (international conference of harmonization)
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Proficiency in MS Office such as Excel / MS PowerPoint / MS Word
Fluent in English and good German language skills
Proven analytical skill to assimilate information quickly and extract relevant data
strong communication skills
high level of self motivation and ability to work self-organized
proactive, mature and eager learning attitude
Our offer:
We are offering a profound familiarization, the integration to a professional team celebrating the advantage of a
small site with 50 colleagues in place and the advantage of being part of a multinational company with 11.700 people
worldwide at the same time. Our employees benefit by being part of UL from an attractive continuous training
program to develop your personal and professional skills and from the career opportunities of a global company. Via
an incentive plan you are directly participating in the company’s success.
How does this sound to you? Did this awaken your interest? Then please send us your application including CV and
motivation letter mentioning your current salary and earliest start date. Your contact person is Sarah Au. If you have
questions in advance please reach out to her via phone +49-69-48 98 10 135
UL International GmbH
Grenzenstraße 13
88416 Ochsenhausen / Germany
T: +49 7352 - 9114-0
Webseite: ul-mdt.com
Ihre Ansprechnpartnerin:
Sarah Au
Personalabteilung
Tel. +49 - 69 - 48 98 10 135
eMail [email protected]