1 Opening(s)
8.0 Year(s) To 10.0 Year(s)
12.00 LPA TO 15.00 LPA
Job Overview:
The Manager – Global Statutory Compliance will be responsible for ensuring the company's dental implants and medical devices adhere to international regulatory standards, including ISO 13085, FDA, and other country-specific statutory requirements. This role will involve overseeing the creation and management of Design History Files (DHF), ensuring proper document ...
1 Opening(s)
2.0 Year(s) To 3.0 Year(s)
3.00 LPA TO 3.60 LPA
Knowledge of Clinical Evaluation Reports (CER) as per EU MDR, MEDDEV 2.7/1 Rev 4.
Perform the risk benefit analysis as per ISO 14971 to demonstrate the medical device benefits outweighed the residual risk.
Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMS and PMCF Plans/Reports, SSCPs, Regulatory Responses ...
1 Opening(s)
2.0 Year(s) To 4.0 Year(s)
4.00 LPA TO 7.00 LPA
Quality Assurance Specialist Responsibilities:
Ensure product quality and conformity to regulatory standards, including Medical Device Regulation (MDR) and Quality Management System (QMS).
Conduct internal quality audits and participate in management review meetings.
Handle investigations of complaints and implement corrective and preventive actions.
Maintain and update quality manuals, formats, and standard operating procedures (SOPs) in ...