Senior Clinical Evaluator Medical Devices - Berlin, Deutschland - ZEISS Group

ZEISS Group

Geprüftes Unternehmen

Berlin, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Your Role- Strategy development of clinical options and documents for new intraocular lenses with relevant interfaces (R&D, Marketing, Quality, SSC, etc.)- Identification and analysis of clinical regulatory requirements relevant for approvals as well as derivation of clinical strategies for international registration in main markets- Collaboration with clinical research department on clinical trial strategy (CDP).

Definition of appropriate design of pre
- or post-approval clinical trials sponsored by Carl Zeiss Meditec

Assessment of risks as well as timelines, economic factors and definition of appropriate mitigation measures
Participation in product risk analysis and benefit risk determination for new or already registered products
Participation in global crosslocation projects for new registrations, approval of product changes or changed requirements triggered by legislative changes
Creation and writing of the set of clinical documents required for registration and maintenance of medical devices including CEP, CER, PMCF plan and report, PMS plan and report, State of the Art, SSCP

Your Profile- minimum 5 years of experience in Clinical Affairs/Clinical evaluation in the medical device industry or with contract research organizations- good knowledge of relevant regulatory requirements for clinical trials for medical devices (ICH-GCP, ISO in-depth expertise of relevant regulatory requirements in clinical evaluations for medical devices (MDR, MDCG, MEDDEV)- understanding of ISO 11979 series and ISO TR 22979 and / or of Chinese and US-FDA regulation for intraocular lenses would be a plus- ability to act independently while effectively collaborating within a team environment- business fluent in English; fluency in other languages (e.g.

French/German/Chinese) is considered an advantage

Your ZEISS Recruiting Team:
Norman Funk