Director Quality Assurance & Regulatory Affairs - the Netherlands

Function Group: Quality/RA / QA Director

Introduction

QTC Recruitment is a reliable recruitment partner, specialising in search and selection of professionals in the life sciences industry. We provide tailored services all over Europe, offering a search proposal to find specialised candidates for demanding positions in a competitive labour market. Through decades of experience in life sciences recruitment, we have developed an extensive network of leading employers and specialists in Europe. Our goal is to make both clients and candidates happy with a new job opportunity or a matching specialist through our reliable, transparent, and personal way of doing business. QTC is all about making a difference for you on Quality, Time and Cost.

Organization

Our client is a global operating organisation in the medical devices industry, present in countries all over the world. This organisation is constantly focusing on developing high quality and innovative products to improve and simplify healthcare.

Function

As a Director Quality Assurance & Regulatory Affairs, you develop and guide the quality and regulatory strategy of the organisation. With your extensive experience in leading quality and regulatory teams, your people management skills, and your thorough knowledge of international regulatory compliancy, you will have a key role in further developing the international growth of the company.

Responsibilities:

  • Development and execution of QA/RA strategy
  • Management of the QA/QC/RA departments
  • Maintenance and improvement of the QMS
  • CAPA management
  • Quality improvement projects
  • MDD/MDR readiness
  • Management of pre and post marker related regulatory affairs
  • Leading internal/external audits

Requirements

  • Bachelor or Master preferably in a technical field
  • 8+ years experience and a proven track record in QA/RA management in the medical devices industry
  • Strong negotiation and mediation skills to internal and external stakeholders such as authorities, notified bodies, management and suppliers
  • Extensive knowledge of international regulatory requirements and legislation (ISO13485, FDA, JPAL, CMDCAS etc.)
  • Excellent communication and people managent skills
  • Strong experience and network regarding key opinion leaders

Information

Interested in this challenge or do you like to know more? Feel free to get in touch with me.

Application

Rick Venneman
Senior Consultant

+31 (0)23 754 8660
+31(0)6 40916403
r.venneman@qtcrecruitment.com

Apply

Contact

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