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- Tasks: Ensure compliance with medical device regulations and author technical documentation.
- Company: Join Microsoft, a leader in empowering healthcare through innovative technology.
- Benefits: Enjoy a diverse workplace, growth opportunities, and the chance to make a real impact.
- Why this job: Be part of a team that values innovation, collaboration, and making a difference in healthcare.
- Qualifications: Experience in software compliance and technical documentation is essential; advanced degrees preferred.
- Other info: Opportunity to work on cutting-edge healthcare data platforms and AI products.
The predicted salary is between 48000 - 72000 £ per year.
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 design and implement 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 Subject Matter Expert (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.
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.
Senior Medical Device Specialist employer: Microsoft
Contact Detail:
Microsoft Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Device Specialist
✨Tip Number 1
Familiarise yourself with the latest regulations and standards related to Software Medical Devices, such as ISO 13485 and ISO 27001. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and quality management.
✨Tip Number 2
Network with professionals in the healthcare regulatory field, especially those who have experience with software compliance. Attend industry conferences or webinars to connect with potential colleagues and learn about current trends and challenges in the sector.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences where you successfully managed regulatory compliance or contributed to technical documentation for medical devices. Highlighting these instances can set you apart during the interview process.
✨Tip Number 4
Showcase your passion for improving patient care and your understanding of how technology can enhance healthcare outcomes. This alignment with Microsoft’s mission will resonate well with the hiring team and demonstrate your fit for the role.
We think you need these skills to ace Senior Medical Device Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in software compliance and regulatory work. Emphasise any specific projects or roles that align with the responsibilities of a Senior Medical Device Specialist.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for healthcare technology and your understanding of regulatory frameworks like ISO 13485 and ISO 27001. Use specific examples to demonstrate how your background makes you a great fit for the role.
Highlight Technical Documentation Skills: Since the role requires authoring technical documentation, be sure to mention your experience in this area. Provide examples of documents you've created or contributed to, particularly in regulated industries.
Showcase Cross-Functional Collaboration: Mention any experience you have working with engineering and project management teams. Highlight how you’ve contributed to audits or developed guidance materials, as this aligns with the collaborative nature of the position.
How to prepare for a job interview at Microsoft
✨Understand the Regulatory Landscape
Familiarise yourself with the key regulations governing Software Medical Devices, such as ISO 13485 and ISO 27001. Be prepared to discuss how your experience aligns with these standards and how you can contribute to compliance efforts.
✨Showcase Your Technical Documentation Skills
Prepare examples of technical documentation you've authored in the past, particularly related to medical devices. Highlight your ability to create clear, concise, and compliant documents that meet regulatory requirements.
✨Demonstrate Cross-Functional Collaboration
Be ready to share experiences where you've worked with engineering and project management teams. Emphasise your role in ensuring robust regulatory oversight and how you contributed to successful audits or compliance initiatives.
✨Embody the Company Culture
Research Microsoft’s values and mission, and think about how they resonate with your own professional philosophy. During the interview, express your commitment to inclusion, integrity, and collaboration, showing that you would be a great cultural fit.
