Our client is an internationally recognized manufacturer of orthopedic implants and endoscopic surgical equipment. Their focus is on consistent innovation, continuous development and providing an extensive training program to surgeons across the world.
To strengthen the German headquarters in Baden-Württemberg, they are looking for a Director of Regulatory Affairs and Quality Management to lead the team of 6 employees and report directly to the CEO. You will be a part of the management team and the leader of RAQM on an international level.
- Contact person for national and international authorities, customers, suppliers and employees in all quality-related questions
- Implementation of international regulatory requirements, if necessary
- Maintaining, monitoring and improvement of the current QM system in accordance with ISO 13485:2016, FDA CFR 21 Part 820 and other national and international requirements as well as the specified customer requirements
- Internal and external audits (incl. supplier audits)
- Monitoring of suppliers for compliance with the contractually agreed quality requirements
- Creation, review and release of documents related to the quality management system and the technical documentation
- Implementation and maintenance of processes and corresponding quality-relevant documents as well as initiating necessary actions in all departments and monitoring their implementation
- Processing and monitoring of international product registrations
- Ensuring that the awareness for correct fulfilling of regulatory and customer requirements is available at all levels through appropriate training measures
- Monitoring of complaint handling activities and CAPAs
- Leadership experience is necessary
- Profound knowledge of applicable national and international regulatory requirements, including ISO 13485:2016, MDD 93/42/EEC, MDR 745/2017 and FDA 21 CFR 820
- Experience in project management
- Experience in process validation including software validation
- Very good skills for handling MS-Office Software
- Very good command of English and German
- Positive attitude with a results-oriented approach to work
- Strong organizational and communicational skills
- Willingness to learn and capacity for team work
- Entrepreneurial thinking
Please contact Rebecca Stevens, Kasia Krasuska or Hollie Barry for more information on this opportunity, and others in RAQM.