Regulatory Compliance Expert
hace 3 días
We are seeking a highly skilled Regulatory Compliance Expert to join our team at Microport Orthopedics. As a member of our Regulatory Affairs department, you will be responsible for ensuring the compliance and safety of our medical devices throughout their lifecycle.
Main Responsibilities:
- Developing and implementing regulatory strategies to ensure compliance with industry regulations, including FDA and European Medical Device Regulation.
- Conducting thorough reviews of product complaints, international registries, and governmental databases to identify trends and patterns.
- Collaborating with cross-functional teams to identify and mitigate risks associated with new products under development.
- Providing support to the Product Development Engineers in developing DFMEA and Risk Analysis plans for new products under development.
- 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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