Quality and Regulatory Affairs Lead
Vor 4 Tagen
Job Summary
CM Medical Recruitment is seeking a highly experienced Quality and Regulatory Affairs Lead to oversee the company's EMEAI warehouse facilities and third-party distributors across the region. The successful candidate will ensure high-quality and compliant distribution of medical devices, pharmaceuticals, and combination devices.
Key Responsibilities
- Quality Management
- Develop and implement quality management systems to ensure compliance with regulatory requirements.
- Conduct regular audits and assessments to identify areas for improvement.
- Collaborate with cross-functional teams to resolve quality-related issues.
- Distribution Management
- Oversee the distribution of medical devices, pharmaceuticals, and combination devices to ensure timely and compliant delivery.
- Develop and maintain relationships with third-party distributors and suppliers.
- Monitor distribution performance and quality to identify trends and areas for improvement.
- Regulatory Compliance
- Ensure compliance with FDA, European Union, and other international regulatory requirements.
- Develop and implement regulatory strategies to ensure compliance with changing regulations.
- Collaborate with regulatory affairs teams to resolve compliance-related issues.
Requirements
- At least 8+ years of progressive work experience in quality and regulatory affairs.
- Current, in-depth knowledge of FDA, European Union, and other international regulatory and quality requirements.
- Advanced knowledge of regulatory frameworks and requirements for EU MDR.
- Experience with hosting regulatory and notified body inspections.
- Fluency in German and English.
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