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:

  • Define needs regarding clinical safety and clinical performance of the device;
  • Evaluate if there are clinical data available and determine equivalence in case of possible equivalence to an existing device
  • Carry out a gap analysis and define which data still need to be generated with the device under evaluation, whether clinical investigations are necessary
  • Initiate Clinical Trial if needed (authorization at authorities, authorization ethics committee)
  • Supports generation of required documentation to initiate clinical trials (CFRs, Protocol, Investigator brochure, …)
  • 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

What we look for:

  • MD or PhD in life sciences
  • Experience working with Medical Devices according to MDD/MEDDEV 2.7.1/ISO14155/ISO13485 standards
  • Demonstrable clinical evaluation skills
  • Experience in conducting clinical studies
  • Knowledge of European regulatory environment
  • Knowledge of/experience with medical writing, literature searches, scientific work, risk-benefit assessment, post marketing clinical follow-up
  • Fluent in English (plus working knowledge of at least one other European language)

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.