
Medical Device Compliance Expert
3 days ago
We are seeking a seasoned Executive - Quality Assurance / Regulatory Affairs expert to spearhead quality management and regulatory compliance for our esteemed client in the Medical Device Industry.
Job Overview:
The ideal candidate will have 5-7 years of experience in the Medical Device Industry, with a thorough understanding of quality systems and regulatory frameworks. They will oversee risk assessment, clinical evaluation, and post-market surveillance for Class I, II, and III medical devices, ensuring adherence to ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.
Key Responsibilities:
- Ensure conformity to relevant regulatory requirements
- Coordinate with local authorities for obtaining necessary permits and approvals
- Manage regulatory submissions and guarantee timely approvals
- Handle Corrective and Preventive Actions (CAPA) to maintain compliance and drive continuous improvement
- Support audits, inspections, and ensure readiness for regulatory authority reviews
Required Skills and Qualifications:
- Thorough understanding of quality systems and regulatory frameworks
- Hands-on experience with regulatory submissions, PMS, and risk management
- Excellent knowledge of GMP, GDP, and ISO 13485 standards
- Strong communication, documentation, and coordination skills
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