Regulatory and Quality Expert
23 hours ago
Fresenius Medical Care is a leading healthcare company that develops and manufactures innovative medical products. We are currently seeking a highly skilled Regulatory and Quality Expert to join our team.
Key Responsibilities:
- Manage and maintain the local Quality Management System (QMS) as Local Management Representative.
- Implement corporate requirements and adapt them to local regulations, creating local instructions as needed.
- Establish, improve, and monitor quality processes, ensuring regulatory compliance for national business operations.
Requirements:
- Bachelor's degree in Pharmacy, Chemical/Bioengineering, Health Sciences, or a related scientific discipline.
- Minimum 5 years of professional experience in quality management systems for medical devices or medicinal products in a regulated environment.
- Strong understanding of Quality Management Systems, ISO 9001/13485, UK/EU MDR/MDD, and Good Distribution Practice (GDP).
- Proficient in Microsoft Office and relevant QMS software (e.g., QTrack).
The estimated salary for this position is around €60,000 - €80,000 per year.
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