Head of Regulatory Affairs & Quality Management (Remote)

Head of Regulatory Affairs & Quality Management

A company is looking for an experienced overall manager for the area of Regulatory & Quality Management, who will take over the excellent existing basis and develop it further in the future together with an experienced and motivated team. This refers in particular to the introduction of lean processes and supporting digital tools, as well as the transfer of own experience in the design implementation of the MDR. This function reports directly to the management.

Industry: Medical Technology / Dental.

Your tasks

• Head of the Quality Management and Regulatory Affairs Department.
• Leadership, motivation and development of the team according to lean principles.
• Development, implementation and monitoring of the Quality Management System (QMS).
• Ensuring compliance with ISO standards (e.g. MDR, ISO 9001, ISO 13485).
• Conducting and coordinating internal and external audits.
• Implementation of improvement measures based on audit results and quality indicators.
• Ensuring compliance with all relevant regulatory requirements at national and international level.
• Support and coordination of product approvals and registrations.
• Communication with national and international regulatory authorities.
• Monitoring changes in legal and regulatory requirements and their implementation.
• Ensuring complete and up-to-date documentation of all quality- and regulatory-relevant processes and procedures.
• Further digitization and optimization of the existing integrated management system.
• Monitor compliance with company policies and procedures.
• Development and implementation of compliance programs.
• Training and raising awareness of employees on quality and compliance issues.
  
  
  

Your profile

• Successfully completed university degree in engineering or natural sciences or comparable training with substantial practical experience.
• Several years of responsibility in a comparable role in an international, manufacturing company.
• In-depth knowledge of the relevant standards such as EU MDR 2017/745 and ISO 13485.
• Experience with the introduction and use of software tools for the field of RA / QM.
• Demonstrable leadership experience.
• Experience with experience with international regulatory authorities and corresponding audits.
• Passion for quality and customer relationships.
• Fluent in German and English.
• Team player with experience and assertiveness in matrix organizations.
  
  
  

The role offers

• Participation in the success of the company through variable remuneration.
• Member of the senior management team in a solid and long-term oriented family business.
  
  
  

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