Senior Medical Device Specialist
Job Summary
Job Description
Microsoft seeks a Senior Medical Device Specialist with a strong technical background and customer-driven passion for regulatory work. Responsibilities include ensuring compliance with regulations (ISO 13485, ISO 27001, ISO 62304), authoring technical documentation, implementing validation protocols, conducting audits, serving as a SME for Medical Device guidance, and potentially contributing to other compliance programs. The role requires experience in Software compliance product/technical program management and writing technical documentation for Medical Devices.
Must have:
- Software compliance experience
- Medical Device documentation experience
- Regulatory, quality, or risk management experience
- Compliance with ISO standards (13485, 27001, 62304)
- Technical program management
Good to have:
- Advanced degree in Regulatory or Healthcare compliance
- Experience with SaMD and device CDS
- Software testing and validation experience
- Regulatory Affairs Certification (RAC)
- Experience with legal/regulatory teams
2 skills required
Job Details
Job Description
Overview
Microsoft is dedicated to empowering healthcare organizations to achieve their goals and improve patient care.
We are looking to hire a Senior Medical Device Specialist, with a strong technical background and a customer-driven passion for regulatory work, to join our team. This is an opportunity to join a growing organization focused on healthcare-specific data platforms, AI products and Microsoft Cloud for Healthcare. We are looking for someone who will bring Medical Device and Regulatory expertise, with a focus on software to our team.
We are a team that believes in making a difference and bringing a positive approach to challenges. If you are looking for a team that will have an impact on an evolving society, provide a diverse workplace, and challenge you to learn and grow, our team may be the place for you.
Microsoft’s mission is to empower every person and every organization on the planet to achieve more. As employees we come together with a growth mindset, innovate to empower others, and collaborate to realize our shared goals. Each day we build on our values of respect, integrity, and accountability to create a culture of inclusion where everyone can thrive at work and beyond.
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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