Senior Medical Device Specialist

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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 seek someone with Medical Device and Regulatory expertise, especially in software.

Our team believes in making a difference, bringing a positive approach to challenges, and creating an inclusive, diverse workplace that encourages learning and growth. If you want to impact society positively and thrive in a collaborative environment, consider joining us.

Microsoft’s mission is to empower every person and organization on the planet to achieve more. We foster a culture of respect, integrity, and accountability, where everyone can thrive.

Responsibilities

1. Ensure compliance with regulations governing Software Medical Devices, including ISO 13485, ISO 27001, and ISO 62304, and support the Quality Management System (QMS).
2. Author technical documentation and design and implement Medical Device validation protocols for software-focused programs.
3. Conduct and contribute to Medical Device audits, collaborating with engineering and project management teams to ensure robust regulatory oversight and documentation.
4. Serve as a Subject Matter Expert (SME) for engineering and other teams, proactively updating and developing Medical Device guidance materials for healthcare services.
5. Apply cross-functional knowledge to other compliance programs as needed.
6. Embodies our Culture and Values.

Required Qualifications

1. Experience in software compliance, product/technical program management, or equivalent.
2. Experience in writing technical documentation for Medical Devices or similar regulated industries.
3. Professional experience in regulatory, quality, clinical evaluation, risk management, or technical program management roles.

Preferred Qualifications

1. Advanced degree in Regulatory or Healthcare compliance.
2. Knowledge of healthcare regulatory landscape, including SaMD, device CDS in the US, and Medical Device Software in the EU.
3. Experience testing and validating software systems.
4. Regulatory Affairs Certification (RAC) for Devices, ISO 13485 auditor, or similar credentials.
5. Experience working with legal/regulatory teams to translate requirements into engineering plans.
6. Experience with consumer-focused software solutions.

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