Senior Quality and Regulatory Consultant

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.

Originally posted on Himalayas