Employee in Quality Management and/or Regulatory Affairs(m/w/x)

Beschreibung

In this role, you will engage in various quality management and regulatory affairs tasks, including optimizing processes and liaising with regulatory bodies. Your day-to-day responsibilities will involve ensuring compliance, supporting clinical evaluations, and participating in audits to enhance product safety and effectiveness.

Anforderungen

• •Experience or training in Quality Management, preferably in the medical device sector (ISO 13485) or any industry with high regulatory standards
• •Knowledge of EU MDR and experience with Class II or higher medical devices
• •Familiarity with clinical evaluations and post-market surveillance processes under MDR guidelines
• •Knowledge of international regulations and certifications for medical devices
• •Fluency in German and English (written and spoken)
• •Flexibility and teamwork orientation in an international environment

Aufgaben

• •Support and collaborate in Quality Management
• •Control, improve, and optimize quality management processes
• •Create and review deviation reports, risk management plans, and CAPA
• •Monitor corrective actions thoroughly
• •Implement and monitor regulatory requirements for medical devices
• •Assist with international product certifications and approvals
• •Liaise with regulatory bodies and authorities
• •Support clinical evaluations for medical devices
• •Participate in post-market surveillance activities
• •Monitor product performance and manage feedback loops
• •Support internal and external audits and supplier audits
• •Assist R&D with documentation and development processes

Benefits