Regulatory Compliance Specialist
2 days ago
Job Summary:
The Sol-Millennium Medical Group is seeking a highly skilled Regulatory Compliance Specialist to join our team. In this role, you will be responsible for ensuring regulatory compliance to applicable international country-specific requirements and policies.
Key Responsibilities:
- Regulatory Compliance: Ensures regulatory compliance to applicable the relevant international country-specific requirements and policies.
- Complaints, CAPAs, and NCRs: Timely reporting of complaints into the document control platform, supports complaint evaluation and investigation, and reviews quality and manufacturing records.
- Quality Assurance: Ensures compliance with ISO 13485, MDD/ MDR, and other applicable regulations and standards.
- Supplier Quality Assurance: Interacts and coordinates activities with other departments, external vendors, and customers.
- Internal and External Audits: Supports internal, external, and customer audits of the SQA program.
Requirements:
- A diploma, certificate, or other evidence of formal qualification in law, medicine, pharmacy, engineering, or another relevant scientific discipline.
- At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
- Knowledge of the medical devices EU regulations, ISO 13485 or ISO 9001 standards, and ASQ certification.
- Experience in Quality Assurance for medical devices, good working knowledge of Microsoft Office, and writing and approving standard operating procedures and work instructions.
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