Orthopedic Post-Market Review Engineer

hace 6 días


San José, San José, Costa Rica Microport Orthopedics S.A. A tiempo completo
About the Role

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:

  1. Conducting comprehensive reviews of product complaints, international registries, and governmental databases to identify trends and patterns.
  2. Developing and implementing post-market surveillance strategies to ensure compliance with industry regulations.
  3. Collaborating with cross-functional teams to identify and mitigate risks associated with new products under development.
  4. Providing support to the Regulatory Affairs group with new product submissions and license renewals.
  5. 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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