Post Market Device Efficacy Specialist
2 weeks ago
About Post Market Surveillance Manager
This role involves ensuring the ongoing safety and effectiveness of medical devices. Key responsibilities include gathering and analysing post-market data, conducting medical impact assessments, managing global adverse event reporting, and authorising key documents.
As a senior professional in this field, you will own the critical system for post-market surveillance, with expertise in regulations such as EU MDR and FDA MDR.
Prior experience in quality management systems, risk management standards, and technical writing is essential. You should be able to analyse complex data and communicate findings effectively to stakeholders.
The ideal candidate will have a strong understanding of medical device regulations and industry trends. Strong interpersonal and communication skills are required for effective collaboration with internal teams and external partners.
About The Role- PMS System & Compliance Management: Manage, maintain, and continuously improve the PMS system, documentation, and all related procedures.
- Regulatory Compliance: Ensure the PMS plan is executed on schedule, coordinating with cross-functional stakeholders to gather inputs and ensure global compliance (EU MDR, FDA, TGA, MEDSAP).
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