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Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
ID: 131742

Director of Quality & Regulatory Affairs

  • MedTech
  • Asap
  • Quality & Change Management, Capacity Building
  • K-Recruiting GmbH
Ansprechpartner:

Julius Strack

+49 89 1890998-614

julius.strack@k-recruiting.com

Overview

Availability
Asap, full-time, onsite & remote
Qualification
Master in Management Analytics, Bachelor in Biomedical Engineering, Regulatory Affairs Manager Certificate
Language Skills
German (native), English (business fluent)
Relevant Expertise
Interim Management, Consulting & Auditing, Digital Transformation & Management Analytics, Project Management, Regulatory Affairs & Risk Management, Quality & Change Management, Verification and Validation, Capacity Building

Key-Facts

  • In-depth knowledge in the implementation and optimization of quality management systems according to ISO 13485 and EU MDR standards

  • Successful projects in the areas of CAPA, supplier management, and EN ISO 13485 audits

  • Strong combination of technical and analytical expertise

Extract from previous activities

2023 – 2024

Medical Device Company, Germany

Chief Strategy Officer

  • Leading strategic planning, business development, and client relationship management

  • Overseeing Quality and Change Management processes

  • Supporting financial planning initiatives

2021 – 2023

Medical Device Company, Germany

Director of Quality & Regulatory Affairs

  • Served as Quality Management Representative (ISO 13485) and Person Responsible for Regulatory Compliance (EU MDR 2017/745)

  • Head of the Quality and Regulatory Affairs Department, leading regulatory strategies and compliance audits

  • Promoted awareness of quality expectations and customer requirements within the organization

  • Led internal, external, and supplier audits

2018 – 2021

Medical Device Company, Germany

Senior Manager, Quality & Regulatory Affairs

  • Directed the QM/RA department and served as the Person Responsible for Regulatory Compliance

  • Managed the organizational management system and maintained compliance with EU MDR, ISO 13485, ISO 14971, IEC 62304 and IEC 60601-1

  • Led the internal audit team and managed audit processes