Orthopedic Post-Market Review Engineer
hace 6 días
As an Orthopedic Post-Market Review Engineer at Microport Orthopedics, you will be responsible for ensuring the highest level of quality and safety in our medical devices. This is a key role that requires strong analytical and problem-solving skills, as well as excellent communication and technical writing abilities.
Key Responsibilities:
- Conducting comprehensive reviews of product complaints, international registries, and governmental databases to identify trends and patterns.
- Developing and implementing post-market surveillance strategies to ensure compliance with industry regulations.
- Collaborating with cross-functional teams to identify and mitigate risks associated with new products under development.
- Providing support to the Regulatory Affairs group with new product submissions and license renewals.
- Creating and maintaining documentation, including clinical evaluation reports, device registries, and periodic safety update reports.
Requirements:
- Bachelor's Degree in a Science/Engineering/Technical field; Master's Degree preferred.
- Minimum 3 years of experience in a related field, including a combination of internship and/or research experience.
- Strong understanding of regulatory requirements, including FDA and European Medical Device Regulation.
- Excellent communication and technical writing skills, with the ability to distill complex information into concise reports.
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