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Quality and Regulatory Affairs Manager (QMB)

Quality and Regulatory Affairs Manager (QMB)

Job Title: Quality and Regulatory Affairs Manager (QMB)
Contract Type: Permanent
Location: Stuttgart, Baden-Württemberg
Industry:
Salary: €60000 - €70000 per annum
Start Date: ASAP
Reference: ID135062_1611305796
Contact Name: Michael Burgstaller
Contact Email: m.burgstaller@sciproglobal.de
Job Published: January 22, 2021 08:56

Job Description

Cleint: A small medtech manufacturer in the field of interventional cardiology

Tasks:

  • He/she improves procedures that maximize quality and regulatory standards; directing development and manufacturing of class IIb medical devices.
  • Ensures the promotion of awareness of applicable requirements throughout the company and reports to top management.
  • Provides leadership in responding to regulatory agencies (EU and worldwide) and manages international audit programs.
  • Executes control over the following systems: company policy, notifiable events, CAPA, change control, documentation control, product complaint investigation and analysis.
  • External interaction includes customer/supplier audits, quality and regulatory agreements, identifying product quality and regulatory trends; recommending corrective actions, initiating and directing local market approvals with partner or 3rd party agencies.
  • Reviews procedures of departments by recommending solutions to problems or changes in procedures.
  • Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications; establishing personal networks and benchmarking of state-of-the-art practices.
Voraussetzungen:
  • Education in engineering, science or QM
  • Significant experience in Quality Management Systems (Medical Devices)
  • Experience with notified bodies, audit procedures and problem solving
  • Knowledge of European regulations and standards (Medical Device Directive, Medical Device Regulation and EN ISO13485:2016)
  • Preferably knowledge of MDSAP, especially related to Australia, Brazil and USA
  • Ability to conduct internal audits and supplier audits
  • Ability to collaborate and communicate cross-culturally and cross-functionally
  • Ability to work effectively in a quickly changing, demanding environment
  • Hands-on mentality with pragmatic attitude, approachable and open-minded
  • Demonstrated leadership skills and willing to work in a small QM team
  • Business fluent German and English (spoken and written)

CV: M.burgstaller@sciproglobal.de