
Lead Medical Device Quality Assurance Professional
1 day ago
We are seeking an Executive - Quality Assurance / Regulatory Affairs professional to lead our medical device industry client through regulatory compliance and quality management.
Key Responsibilities:
- Ensure Compliance: Manage ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements for Class I, II, and III medical devices.
- Coordinate with local authorities for obtaining necessary permissions and approvals.
- Risk Management: Oversee clinical evaluation, post-market surveillance (PMS), and Corrective and Preventive Actions (CAPA) to maintain compliance and continuous improvement.
- Manage regulatory submissions and ensure timely approvals.
- Regulatory Expertise: Utilize strong knowledge of GMP, GDP, and ISO 13485 standards to support audits, inspections, and regulatory authority reviews.
Candidate Profile:
- Strong understanding of quality systems and regulatory frameworks for medical devices.
- Hands-on experience with regulatory submissions, PMS, and risk management.
- Excellent Communication Skills: Strong communication, documentation, and coordination skills to collaborate with cross-functional teams.
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