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Head of Quality and Regulatory Affairs

Job type:
Permanent
Sector:
Life Sciences
Location:
Berlin
Salary:
£0.00 per annum
Date posted:
11/08/2017
Job reference:
BBBH7453_1502463766

HEAD OF QUALITY & REGULATORY AFFAIRS (M/W)


Job title: Head of Quality & Regulatory Affairs (m / f)

Tasks

  • You manage and supervise the areas QA, QC (at the location in Bodelshausen) and Regulatory Affairs, report directly to senior management.
  • Continuous development and maintenance of effective quality management system according to ISO 13485 and CFR Part 820 QSR in the international environment.
  • Assuming the function of the quality management officer.
  • Preparation and execution of internal audits and supplier audits, as well as communication with the Notified Body and international authorities (FDA).
  • Responsibility for risk management in accordance with ISO 14,971th
  • In exchange for the development, production, marketing and management, you define a strategy on quality and the quality targets and make the achievement of objectives safely.
  • Maintaining all regulatory requirements and implementation of new regulatory requirements.
  • Support for Validation of medical software / computer-aided systems.
  • Planning and implementation of staff training.
  • Participation in the CAPA and Risk Management Team.


Requirements
for this position, we expect

  • University education with a specialization in medical / biology or in a comparable field of study.
  • Several years of professional and management experience in a similar position and responsibility.
  • Experience in regulatory affairs, desirably in the approval of IVDs.
  • Experience working with ERP systems, ideally MS Dynamics Navision.
  • Very good knowledge in the field of quality management systems (13485).
  • FDA audit experience desirable.
  • Very good knowledge of the 98/79 / EEC and other international standards in the field of diagnostics.
  • Very good command of written and spoken.
  • Excellent communication and interpersonal skills, assertiveness and diplomatic skills and a high focus on implementation.
  • High degree of personal responsibility, reliability and quality awareness.

 

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