Medical Device Investigator

Key Responsibilities:

1. Medical Device Complaint Investigation:

o Lead and manage the investigation of medical device complaints to ensure timely and accurate reporting.

o Review and analyze data related to product complaints, identify root causes, and implement corrective and preventive actions.

o Coordinate with cross-functional teams to resolve complaints and ensure compliance with regulatory requirements.

2. Post Market Surveillance (PMS):

o Oversee and ensure effective post-market surveillance activities for medical devices to track and monitor product performance.

o Identify trends and potential risks to ensure early detection of adverse events and maintain product safety.

3. Compliance & Regulatory:

o Ensure compliance with relevant standards, including ISO 13485, USFDA, and EUMDR, for complaint investigations and product safety monitoring.

o Assist in the preparation for audits, inspections, and regulatory submissions.

o Maintain up-to-date knowledge of regulations and standards governing medical devices.

4. Team Management & Leadership:

o Lead and manage a team of investigators, ensuring high-performance levels and adherence to timelines.

o Provide training, guidance, and mentorship to team members to improve investigation techniques and maintain quality.

o Foster a positive work environment, ensuring team engagement and collaboration.