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Microsoft Senior Medical Device Specialist Taiwan, Taoyuan City 527901098
Yesterday
Job Description
Responsibilities
- Ensure compliance with regulations governing Software Medical Devices including ISO 13485, ISO 27001, and ISO 62304, as well as support for the Quality Management System (QMS)
- Author technical documentation, and designs and implements Medical Device validation protocols for Software focused programs
- Conduct and contribute to Medical Device audits, working with engineering and PM teams to ensure robust regulatory oversight and documentation of the Medical Device program.
- Serve as a SME for Engineering and other organizations, proactively revising and developing Medical Device guidance materials for healthcare services.
- May apply cross-functional knowledge to other compliance programs.
- Embody our and .
Required Qualifications:
- Experience in Software compliance product/technical program management OR equivalent experience.
- Experience writing technical documentation for Medical Devices or other regulated industries.
- Professional experience in a combination of roles in regulatory, quality, clinical evaluation, risk management, technical program management, or equivalent.
Preferred Qualifications:
- Advanced degree in Regulatory or Healthcare compliance.
- Experience of the healthcare regulatory landscape, including SaMD and device CDS for the United States and Medical Device Software for the European Union.
- Experience testing and validating software systems.
- Regulatory Affairs Certification (RAC) Devices, lead ISO13485 auditor, or equivalent.
- Experience working with legal / regulatory teams to translate regulatory and standard requirements to actionable engineering plans.
- Experience with consumer-focused software solutions.
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