Senior Quality and Regulatory Consultant

About Us Orthogonal is a development and consulting firm that creates software such as smartphone apps that talk to medical device hardware that operates directly on the human body to treat sickness and injury. We take on some of the most challenging healthcare problems facing our loved ones, the healthcare system, and society. Working at Orthogonal, you will be exposed immediately to projects designed to: Revolutionize the rapid detection of COVID-19 and other infectious diseases. Improve the minute-by-minute lives of millions of people suffering from the lifetime affliction of diabetes by managing insulin delivery. Transform the early diagnosis of Alzheimer’s disease. Give patients an at-home means to stimulate specific nerves to treat chronic conditions that drag down their quality of everyday life. Power the next generation of omics-based cancer-detection systems. Specifically, Orthogonal develops Software as a Medical Device (SaMD), digital therapeutics (DTx), and other types of connected medical devices. We accelerate the product innovation pipeline at medical device, diagnostics, and pharmaceutical manufacturers to modernize patient care and gain competitive advantage. Orthogonal’s industry-leading experience with SaMD enables the rapid development, launch, and continuous improvement of connected, compliant products – and we offer this innovative approach to clients so that they can build their own SaMD product development workflows. Over the last decade, we’ve worked with partners ranging from startups to Fortune 500 firms to develop and bring their connected devices to market in a highly regulated space. Job Description This is a remote position. Who you are: You think about quality and regulatory strategy from first principles, translating a client's risk and business goals into a right-sized plan rather than a generic playbook. What energizes you is the strategic puzzle of scoping what a project or a client's quality system needs, not running the same process on autopilot. You're comfortable working across a portfolio of engagements rather than being embedded in just one. You're client-focused and solutions-oriented, working just as naturally with clients who are quality/regulatory veterans as with those who are newer to the space. What You'll Do: • Lead assessment and enablement engagements end to end, advising clients directly on their own quality management system, risk management process, and regulatory strategy. • Define project-level quality and regulatory strategy at discovery, in collaboration with the delivery team, determining applicable regulatory requirements and what the project needs to succeed. • Own quality agreements with clients, and serve as the final quality and regulatory reviewer at design transfer, confirming the project's quality plan and medical device file are complete and defensible before transfer. • Partner with the Delivery Manager to reconcile quality and regulatory strategy with project scope, budget, and timeline, finding solutions that satisfy client needs on both fronts. • Build and grow Orthogonal's assessment and enablement practice, and track where SaMD, AI/ML, and digital health regulation is heading. Reports to: VP, Quality & Regulatory (functional/technical); assigned Delivery Manager (project day-to-day) on engagements where a delivery team is in place Escalates to VP, Quality & Regulatory when: a quality or regulatory strategy question can't be reconciled with project scope, budget, or timeline through direct collaboration with the Delivery Manager, or a methodology decision affects engagements beyond one client. Requirements Requirements (candidate must have this experience): • BS or MS in a relevant technical, quality, or regulatory field, or equivalent experience. • 6+ years of experience in medical device or SaMD quality/regulatory consulting or leadership, including direct client advisory work. • Deep, practical fluency with ISO 13485, IEC 62304, ISO 14971, and related standards, working within both US FDA and EU MDR frameworks (additional geographies preferred). • Real experience scoping and defining quality and regulatory strategy for a project or organization, not just executing an existing plan, and comfortable working across a portfolio of engagements at a strategic level rather than being embedded full-time in one. • Strong written and verbal communicator, confident negotiating quality agreements and advising client executives directly. Preferences (you’d be a strong fit if…) • Preferred: Experience building or growing an assessment, enablement, or advisory service line. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. We are unable to hire outside of the U.S. for this role. Benefits Salary range: $130,000-$185,000 Location: Remote within the U.S. Medical, dental, and vision insurance options 401k & 401k matching options Company-provided technology PTO + 10 company holidays Strong work-life balance Flexible work schedule within regular business hours