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MH

Senior Expert Connected Health Quality Lead (all genders)

Merck Healthcare
Posted 2 hours ago
🇨🇭Switzerland🏢Hybrid📁Healthcare/Clinical
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Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role

Connected devices, digital therapeutics and intelligent injection systems are reshaping how patients receive treatment, and you will help make that future safe, secure and compliant. You will lead the quality and regulatory strategy for connected health products from early concept through post-market surveillance. As the quality lead for digital health and software as a medical device, you will own risk management, software quality and cybersecurity compliance across the product lifecycle. You will translate evolving technology and regulatory expectations into clear, practical processes that guide engineering, clinical operations and other cross-functional partners.

You will help close the gaps between rapid technology development and the quality and compliance requirements of the healthcare environment. Working closely with a five-member team, you will collaborate across digital health, cybersecurity, data privacy, electronic autoinjectors, manufacturing quality, clinical evaluation and post-market activities. You will support design controls, technical documentation and clinical evaluation or investigation for products intended for international markets. You will build trusted relationships with auditors, notified bodies, senior stakeholders, external partners and suppliers, influencing decisions even when you do not have direct authority. Based in Eysins, Switzerland, this role offers flexible remote work of up to three days per week. If you are motivated by innovation that keeps patients safe, you will have the opportunity to shape how connected care reaches people around the world.

Who You Are

  • You have at least 10 years of experience in medical device quality and regulatory affairs, including connected or software-driven products.
  • You have strong practical knowledge of the standards and regulations governing quality management systems, risk management, software lifecycle processes, usability and post-market surveillance.
  • You bring hands-on expertise in medical device cybersecurity and data privacy, including threat modelling, security risk management and vulnerability handling.
  • You have supported design controls, technical documentation and clinical evaluation or investigation for devices placed on international markets.
  • You have experience with digital health applications or software as a medical device; experience with electronic drug delivery systems and manufacturing quality is an advantage.
  • You turn complex and changing technology or regulatory expectations into workable processes and communicate confidently with auditors, notified bodies and senior stakeholders in English.
  • You have experience managing external partners and suppliers, including technical agreements, supplier qualification and oversight of outsourced development and manufacturing.
  • You are curious about new technologies, collaborative by nature and energized by work that protects patients; experience applying artificial intelligence in healthcare or medical devices is a plus.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

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