Junior Manager Clinical Evaluation (f/m)

89518 Heidenheim
18.05.2018

Daten dieser Anzeige

Job-ID: 007832794
Junior Manager Clinical Evaluation (f/m)

PAUL HARTMANN AG

Germany

Carry out a gap analysis and define which data still need to be generated with the device under evaluation, whether clinical investigations are necessary Evaluate if there are clinical data available and determine equivalence in case of possible equivalence to an existing device Generate Clinical Evaluation Reports Execution, communication and reporting of feasibility, CE mark and post-marketing studies to enable the company to meet its business objectives. Supports generation of required documentation to initiate clinical trials (CFRs, Protocol, Investigator brochure, etc.)

Junior Manager Clinical Evaluation (f/m) Full Time Heidenheim an der Brenz, Deutschland With Professional-Experience 5/17/18 The HARTMANN GROUP is one of the leading European providers of medical and hygiene products with core expertise being in wound treatment, incontinence care and infection prevention. Its range also includes products for compression therapy and First Aid in addition to care products and cosmetics. Furthermore, HARTMANN offers innovative system solutions for professional target groups in the medical and healthcare sector. The Company, which has its headquarters in Heidenheim/Germany and which has Europe as its focal market, is organised with its own country companies close to the market across the world. In 2017, the 10,764 employees of the HARTMANN GROUP generated sales of EUR 2.06 billion. Your area of responsibility: Carry out a gap analysis and define which data still need to be generated with the device under evaluation, whether clinical investigations are necessary Evaluate if there are clinical data available and determine equivalence in case of possible equivalence to an existing device Generate Clinical Evaluation Reports Execution, communication and reporting of feasibility, CE mark and post-marketing studies to enable the company to meet its business objectives. Supports generation of required documentation to initiate clinical trials (CFRs, Protocol, Investigator brochure, etc.) What we look for: University degree in Biology or natural sciences or higher education in the field of health care Several years of work-experience in a Medical Device company - either in the field of Regulatory Affairs or Quality or as CRA. Experience with literature searches and scientific work - experience in writing clinical evaluations is a plus Beneficial would also be knowledge of risk-benefit assessment, pre- or post marketing clinical follow-up Ideally first experience working with Medical Devices according to MDD/MEDDEV 2.7.1/ISO14155/ISO13485 standards Fluent in English both oral and in writing - German basic knowledge is a MUST Your contact Ms Friederike Stracke PAUL HARTMANN AG, Human Resources Management P.O. Box 1420, 89504 Heidenheim, Germany www.hartmann.info If you wish to join our company, we will appreciate to receive your informative application with cover letter, curriculum vitae and copies of certificates.   Apply online Check other openings by visiting our jobs list Share this job Powered by softgarden

Pharma, Chemie, Med.-/ Biotechnologie

Forschung & Entwicklung

Chemie/ Pharma/ Biotechnologie

Gesundheits-/ Sozialwesen/ Medizin

Angestellter/ Fachkraft

Vollzeit

89518 Heidenheim