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Compliance Specialist for Medical Devices
vor 2 Monaten
Job Type: Freelance/Contract
Position Overview:
As a Freelance Quality Management Expert, you will play a crucial role in ensuring that our quality management system complies with ISO 9001 standards and meets the requirements of the MDR.
You will work closely with our internal teams to oversee document control, traceability, and the implementation of Unique Device Identification (UDI) systems.
Key Responsibilities:
- Ensure that the company's quality management system adheres to ISO 9001 and MDR requirements, providing expert guidance on best practices and continuous improvement.
- Develop, review, and maintain quality documentation, ensuring compliance with regulatory requirements and internal standards.
- Support the implementation and maintenance of Unique Device Identifier (UDI) systems to ensure accurate product identification and traceability.
- Assist in preparing and maintaining documentation necessary for CE Marking of medical devices, ensuring compliance with EU regulations.
- Oversee the traceability of materials, components, and products throughout the production process to ensure compliance with regulatory requirements.
- Provide training and support to internal teams on QMS processes, regulatory requirements, and documentation control.
Requirements:
- Fluency in both German and English.
- Extensive experience working with ISO 9001 in the context of medical devices.
- Strong understanding of the European Medical Device Regulation (MDR).
- Proficiency in document control systems and quality management software.
- Strong analytical, organizational, and communication skills with the ability to work independently and manage multiple tasks.
Company Overview:
EPM Scientific is a leading provider of scientific and regulatory services to the medical device industry. We are committed to delivering high-quality solutions that meet the evolving needs of our clients.
