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Microsoft’s Health and Life Sciences (HLS) team is dedicated to empowering healthcare organizations to achieve their goals and improve patient care. The HLS team aims to create an efficient and connected healthcare ecosystem built on the Microsoft Cloud, empowering everyone across the healthcare journey to collaborate, communicate, and innovate together to provide better experiences for clinicians, staff, and patients.

We are looking to hire a Senior Medical Device Specialist, with a 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 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. We are looking to hire a Senior Program Manager to join our team.

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

We are looking for someone who will bring Medical Device and Regulatory expertise, with a focus on software to our team.

Responsibilities include:

• Ensures compliance with regulations governing Software Medical Devices including ISO 13485, ISO 27001, and ISO 62304, as well as day-to-day management of the Quality Management System (QMS)

• Authors technical documentation, and designs and implements Medical Device validation protocols for Software focused programs

• Conducts 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, including Privacy, and HIPAA.

• Embody our culture (https://careers.microsoft.com/v2/global/en/culture) and values. (https://www.microsoft.com/en-us/about/corporate-values)

Qualifications

Minimum Qualifications:

• Bachelor's Degree in Science, Business, Engineering, or related field AND 4+ years experience in Software compliance product/technical program management, business, legal/regulatory, compliance, audit/consulting firm

• OR equivalent experience.

• 2+ years’ experience writing technical documentation for Medical Devices or other regulated industries.

• 3+ years of professional experience in a combination of roles in regulatory, quality, clinical evaluation, risk management, technical program management, or equivalent.

Other Requirements:

Ability to meet Microsoft, customer and/or government security screening requirements are required for this role. These requirements include, but are not limited to, the following specialized security screenings:

• Microsoft Cloud Background Check: This position will be required to pass the Microsoft Cloud background check upon hire/transfer and every two years thereafter.

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 working on radiology and imaging devices

• 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.

Compliance IC4 - The typical base pay range for this role across the U.S. is USD $94,600 - $183,800 per year. There is a different range applicable to specific work locations, within the San Francisco Bay area and New York City metropolitan area, and the base pay range for this role in those locations is USD $122,000 - $200,500 per year.

Certain roles may be eligible for benefits and other compensation. Find additional benefits and pay information here: https://careers.microsoft.com/us/en/us-corporate-pay

Microsoft will accept applications for the role until November 15, 2024.

#Health&LifeScience #hlsp

Microsoft is an equal opportunity employer. Consistent with applicable law, all qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, color, family or medical care leave, gender identity or expression, genetic information, immigration status, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran or military status, race, ethnicity, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable local laws, regulations and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application process, read more about requesting accommodations (https://careers.microsoft.com/v2/global/en/accessibility.html) .