Client Operations Manager

Develop deep expertise in the Ketryx platform and how it supports regulated development.

Guide teams through advanced product configuration, risk-informed decision-making, and complex problem-solving in safety-critical environments.

Serve as an escalation point for technical challenges, balancing short-term needs with long-term platform integrity.

Act as a strategic advisor and primary point of contact for executive stakeholders.

Translate complex technical and regulatory concepts into clear, actionable recommendations for clients.

Foster trust and satisfaction through consistent delivery, proactive communication, and a client-first mindset.

Provide structured, strategic feedback to influence the product roadmap and internal process evolution.

Partner closely with Engineering, Product, and Quality teams to champion solutions that align with real-world client needs.

Lead initiatives to improve how Client Operations works—scaling our impact through systems, tools, and thoughtfulness.

Mentor and support junior team members, helping them grow into confident, capable professionals.

Model Ketryx’s values through your decisions and demeanor—humble, helpful, exceptional, and curious.

Contribute to a high-trust, high-accountability culture that balances excellence with care.

Oversee the drafting, review, and continuous improvement of formal documents, including SOPs, policies, risk documents, and validation protocols.

Ensure documentation meets both internal quality standards and external regulatory requirements.

Help clients structure and improve their documentation to support audit readiness, scalability, and clarity.

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.

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&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