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:

  • It will be your responsibility for assuring compliance with national and international regulations with regard to post market surveillance
  • You will be responsible for identifying the requirements for, the development of and the establishing and training of post market surveillance based on current applicable standards and regulations
  • You will contribute to various projects chartered by the R&D department, ensure integration of Post Market Process including surveillance results into all facets of the QMS including Clinical Evaluation, Risk Management and Corrective and Preventive Actions
  • You will oversee the development and maintenance of IT systems to support Post Market Surveillance process incl. the maintenance of local and global PMS procedures and forms
  • And you will support answering requests from competent authorities, registries and notified bodies, respectively consolidation and provision of reports, especially as described in European Medical Device Regulation
  • You will be responsible for the regular and timely communication of relevant post market data and trends to key employees throughout the organization
  • Surveillance and coordination of timely Proactive Post Market Surveillance activities
  • Functions as representative for global Post Market Surveillance process during Competent Authority /3rd Party Audits and assists in the preparation and submission of audit responses

What we look for:

  • Bachelor degree in science, medical or engineering - a Master degree is desirable
  • Experience in the field of Post Market Surveillance or Quality Systems would be beneficial– preferably within the medical device industry
  • Sound experience in Regulatory Affairs or Quality Management (Post Market Surveillance would be beneficial) within a global company preferably in the medical device or pharmaceutical industry
  • First experience in Project Management is a plus
  • Ability to define problems, collect data, establish facts and draw valid conclusions
  • Ability to interpret an extensive variety of instructions furnished in written, oral, diagram or schedule form
  • Ability to apply mathematical operations to such tasks as frequency distribution, reliability, analysis of variance etc.
  • Strong computer skills are preferred
  • You are teamplayer and self-motivated person with courage and creativity to find new ways and solution
  • Your English- and German language skill are fluent oral and in writing
  • Audit-proof knowledge of the regulatory requirements of medical device legislation (e.g. MDD / MDR, ISO 13485, 21 CFR 820)

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.