Job Title: Client Operations Manager   Employment Status: Full-time Office Hours: Monday - Friday, 8am - 5pm, flexible hybrid options available Location: Boston, Massachusetts Compensation: $95,000 - $130,000 *compensation may be negotiated based on experience level <hr /> Ketryx is on a mission to save and improve lives by making safety-critical products—and the AI that powers them—safe, secure, and reliable. We empower engineering teams building medical devices and digital health software to move faster with confidence, by automating the complex quality and compliance processes that traditionally slow innovation. As a leader in the emerging field of AI/ML in MedTech, we’re building a new kind of Client Operations team—one that blends technical fluency with systems thinking, operational excellence, and human care. <h2>The role</h2> We’re expanding our Client Operations team to support a growing number of innovative medtech companies who rely on Ketryx to power their safety-critical development processes. As a Client Operations Manager, you’ll lead both people and portfolios—building high-performing teams, owning key client relationships, and ensuring exceptional outcomes across multiple complex engagements. You’ll guide your team through every phase of the client lifecycle, from onboarding through long-term partnership. This includes solving challenging technical problems, optimizing quality and regulatory workflows, and shaping how customers use our platform to bring safer, more effective products to market. Youll also mentor team members, drive continuous improvement initiatives, and serve as a strategic advisor to your clients and to Ketryx leadership. This is a pivotal role in achieving our mission to impact over 20 million patient lives in 2024. It offers a rare opportunity to combine deep technical leadership with meaningful real-world impact—ideal for those who thrive in dynamic, mission-driven environments and care deeply about both how and why the work gets done. <h2>About you</h2> You have experience in regulated industries and understand that compliance isn’t just a checkbox—it’s a promise to build safe, high-quality products. You bring a calm, decisive presence to high-stakes environments, taking full ownership of complex portfolios and ensuring your team delivers with excellence. You build trust quickly—with clients, colleagues, and executives alike—through clear communication, professional integrity, and follow-through. You think systemically, solve problems proactively, and keep teams focused on what matters most, even amidst competing demands. You set a high standard and lead by example. You coach and develop others with care and clarity, fostering a culture of accountability, learning, and shared success. You’re humble but driven—equally committed to your own growth and the growth of those around you. If this sounds like you, we’d love to meet you. <h2>Responsibilities (General)</h2> Lead People and Portfolios <ul> <li>Build and lead high-performing teams that deliver exceptional outcomes across multiple client engagements. </li> <li>Manage the full client lifecycle—from onboarding to long-term partnership—ensuring strategic alignment, operational excellence, and measurable results. </li> <li>Balance client needs, technical constraints, and regulatory requirements to keep engagements on track, on time, and impactful. </li> </ul> Drive Technical Execution and Strategic Configuration <ul> <li>Develop deep expertise in the Ketryx platform and how it supports regulated development. </li> <li>Guide teams through advanced product configuration, risk-informed decision-making, and complex problem-solving in safety-critical environments. </li> <li>Serve as an escalation point for technical challenges, balancing short-term needs with long-term platform integrity. </li> </ul> Own Client Success and Relationship Management <ul> <li>Act as a strategic advisor and primary point of contact for executive stakeholders. </li> <li>Translate complex technical and regulatory concepts into clear, actionable recommendations for clients. </li> <li>Foster trust and satisfaction through consistent delivery, proactive communication, and a client-first mindset. </li> </ul> Shape Product and Continuous Improvement <ul> <li>Provide structured, strategic feedback to influence the product roadmap and internal process evolution. </li> <li>Partner closely with Engineering, Product, and Quality teams to champion solutions that align with real-world client needs. </li> <li>Lead initiatives to improve how Client Operations works—scaling our impact through systems, tools, and thoughtfulness. </li> </ul> Mentor, Develop, and Model Culture <ul> <li>Mentor and support junior team members, helping them grow into confident, capable professionals. </li> <li>Model Ketryx’s values through your decisions and demeanor—humble, helpful, exceptional, and curious. </li> <li>Contribute to a high-trust, high-accountability culture that balances excellence with care. </li> </ul> <h2>Required Skills (General)</h2> People Leadership and Cultural Fit You lead with humility and conviction. You’ve mentored others, modeled high standards, and built teams rooted in trust and growth. You resonate with our values—and want to be part of a culture that is professional, human, and driven by purpose. Experience in Regulated, Safety-Critical Environments You’ve worked in industries where precision, traceability, and safety are non-negotiable—such as medical devices, biotech, pharma, aerospace, or automotive. You understand that regulation exists for a reason, and you’ve operated within formal quality systems as a Quality Manager, Systems Engineer, Technical Project Manager, or in an adjacent leadership role. Technical Fluency and Systems Awareness You’re comfortable navigating complex technical systems, from software architecture and product configuration to quality documentation and V&amp;V protocols. You think in systems, not silos—and you learn new tools quickly. You don’t need to write code to understand how the code fits into the bigger picture. Client Leadership and Strategic Thinking You’ve built trust with senior stakeholders and guided customers through ambiguity and complexity. You balance empathy with rigor—helping clients make hard decisions and seeing the long game without losing sight of near-term wins. Operational Rigor and Continuous Improvement You bring structure, momentum, and focus to your work. You’ve led cross-functional teams or projects, driven change in dynamic environments, and consistently raised the bar. You care about how things get done—and how they could be better next time. Exceptional Communication and Presence You communicate with clarity and calm—whether writing technical documentation, managing a sensitive client conversation, or aligning teams around a goal. You tailor your message to your audience and lead with transparency. Education and Background Bachelor’s degree in a relevant field (e.g., engineering, life sciences, computer science), or equivalent experience. Master’s degree or formal leadership training is a plus but not required—we care more about how you think and lead. <h2>Responsibilities (QA/RA)</h2> Lead People and Portfolios <ul> <li>Build and lead high-performing teams that deliver exceptional outcomes across multiple client engagements. </li> <li>Manage the full client lifecycle—from onboarding to long-term partnership—ensuring strategic alignment, operational excellence, and measurable results. </li> <li>Balance client needs, technical constraints, and regulatory requirements to keep engagements on track, on time, and impactful. </li> </ul> Drive Technical Execution and Strategic Configuration <ul> <li>Develop deep expertise in the Ketryx platform and how it supports regulated development. </li> <li>Guide teams through advanced product configuration, risk-informed decision-making, and complex problem-solving in safety-critical environments. </li> <li>Serve as an escalation point for technical challenges, balancing short-term needs with long-term platform integrity. </li> </ul> Own Documentation and Process Control <ul> <li>Oversee the drafting, review, and continuous improvement of formal documents, including SOPs, policies, risk documents, and validation protocols. </li> <li>Ensure documentation meets both internal quality standards and external regulatory requirements. </li> <li>Help clients structure and improve their documentation to support audit readiness, scalability, and clarity.</li> </ul> Own Client Success and Relationship Management <ul> <li>Act as a strategic advisor and primary point of contact for executive stakeholders. </li> <li>Translate complex technical and regulatory concepts into clear, actionable recommendations for clients. </li> <li>Foster trust and satisfaction through consistent delivery, proactive communication, and a client-first mindset. </li> </ul> Shape Product and Continuous Improvement <ul> <li>Provide structured, strategic feedback to influence the product roadmap and internal process evolution. </li> <li>Partner closely with Engineering, Product, and Quality teams to champion solutions that align with real-world client needs. </li> <li>Lead initiatives to improve how Client Operations works—scaling our impact through systems, tools, and thoughtfulness. </li> </ul> Mentor, Develop, and Model Culture <ul> <li>Mentor and support junior team members, helping them grow into confident, capable professionals. </li> <li>Model Ketryx’s values through your decisions and demeanor—humble, helpful, exceptional, and curious. </li> <li>Contribute to a high-trust, high-accountability culture that balances excellence with care.</li> </ul> <h2>Required Skills (QA/RA)</h2> People Leadership and Cultural Fit You lead with humility and conviction. You’ve mentored others, modeled high standards, and built teams rooted in trust and growth. You resonate with our values—and want to be part of a culture that is professional, human, and driven by purpose. Experience in Regulated, Safety-Critical Environments You’ve worked in industries where precision, traceability, and safety are non-negotiable—such as medical devices, biotech, pharma, aerospace, or automotive. You understand that regulation exists for a reason, and you’ve operated within formal quality systems as a Quality Manager, Systems Engineer, Technical Project Manager, or in an adjacent leadership role. Quality Systems and Regulatory Expertise You’re fluent in the language of quality and compliance. You know how to apply standards like ISO 13485, ISO 14971, IEC 62304, and 21 CFR Part 820, and you’re familiar with CAPA processes, audit preparation, and risk management frameworks. You’ve worked directly with design controls, validation protocols, and post-market documentation—and you know how to help others do the same. Document Ownership and Process Control You’ve authored and maintained policies, SOPs, technical files, and work instructions within a QMS. You understand the discipline required to manage controlled documentation, and the creativity required to make it actually usable. Your documentation aligns with both regulatory standards and operational reality. Technical Fluency and Systems Awareness You’re comfortable navigating complex technical systems, from software architecture and product configuration to quality documentation and V&amp;V protocols. You think in systems, not silos—and you learn new tools quickly. You don’t need to write code to understand how the code fits into the bigger picture. Client Leadership and Strategic Thinking You’ve built trust with senior stakeholders and guided customers through ambiguity and complexity. You balance empathy with rigor—helping clients make hard decisions and seeing the long game without losing sight of near-term wins. Operational Rigor and Continuous Improvement You bring structure, momentum, and focus to your work. You’ve led cross-functional teams or projects, driven change in dynamic environments, and consistently raised the bar. You care about how things get done—and how they could be better next time. Exceptional Communication and Presence You communicate with clarity and calm—whether writing technical documentation, managing a sensitive client conversation, or aligning teams around a goal. You tailor your message to your audience and lead with transparency. Education and Background Bachelor’s degree in a relevant field (e.g., engineering, life sciences, computer science), or equivalent experience. Master’s degree or formal leadership training is a plus but not required—we care more about how you think and lead. Keywords: customer success, professional services, systems engineer, Solutions Architect, Software as a Medical Device, SaMD, product management, technology, client management, quality, regulatory, system engineer, B2B<div><h3>What We Offer</h3> <ul> <li>Competitive compensation</li> <li>Generous stock options possible</li> <li>Work in an exciting field with a positive impact on the world</li> <li>Opportunity to learn and grow as part of a global team</li> <li>Hybrid work model (mix of work from home and office is possible)</li> <li>Generous PTO for full-time</li> </ul> Ketryx is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances Ketryx is saving and improving lives by making medical software safe and reliable. We empower software teams building medical applications to create safe, secure, and compliant products used by patients and providers worldwide. We believe that, by automating much of the documentation and quality processes, teams will be able to produce safer and more innovative medical software faster. Ketryx is at the forefront of helping teams incorporate AI/ML into medical software and that’s why we need you!  </div>