Medical Device Post-Market Safety Specialist
1 week ago
Post-Market Surveillance System Owner
">This role involves overseeing the Post-Market Surveillance system, ensuring ongoing safety and effectiveness of medical devices. You will gather and analyze data from multiple sources, including product complaints, customer feedback, and clinical inquiries.
]The ideal candidate will have a strong background in Bioengineering, Nursing, or a related Health Science. Experience in Medical Device Regulation, Clinical Research, and Data Analysis is highly valued. Advanced degree holders are preferred. At least 8 years of experience in the industry is required, with dedicated experience in Post-Market Surveillance and Vigilance.
]Key Responsibilities
]- Manage and continuously improve the Post-Market Surveillance system, documentation, and procedures.
- Stay informed about new regulations and guidelines, assess their impact on company PMS processes, and drive necessary changes.
- Coordinate with cross-functional stakeholders to ensure global compliance (EU MDR, FDA, TGA, MEDSAP).
- Remain up-to-date with regulatory requirements and implement updates as needed.
Requirements
]- Minimum 8 years of experience in the medical device or pharmaceutical industry.
- Dedicated experience in Post-Market Surveillance and/or Vigilance.
- Strong background in Bioengineering, Nursing, or a related Health Science.
- Experience in Medical Device Regulation, Clinical Research, and Data Analysis.
- Advanced degree holder preferred.
This position plays a critical role in ensuring the ongoing safety and effectiveness of medical devices. By joining our team, you will contribute to the development of life-saving products that improve patient outcomes.
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