Senior SaMD Quality & Regulatory Strategist (Remote)

Orthogonal; Northern (KY); Hybrid; USD 130,000 - 185,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k & 401k matching options

Company-provided technology

PTO + 10 company holidays

Strong work-life balance

Flexible work schedule within regular/

Job summary

Orthogonal is a development and consulting firm that focuses on SaMD and connected medical devices. We seek a Senior Quality and Regulatory Consultant to translate risk and business goals into a right-sized plan and work across a portfolio of engagements rather than being embedded in one client.

You will lead assessment and enablement engagements, define project-level regulatory strategy, own quality agreements, and collaborate with delivery managers to align scope, budget, and timeline while

Qualifications

• BS or MS in a relevant technical, quality, or regulatory field, or equivalent experience.
• 6+ years of medical device or SaMD quality/regulatory consulting or leadership.
• 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.

Responsibilities

• 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.

Skills

Quality strategy

Regulatory consulting

Client advisory

Education

BS or MS in a relevant technical, quality, or regulatory field

Job description

Orthogonal is a development and consulting firm that focuses on SaMD and connected medical devices. We seek a Senior Quality and Regulatory Consultant to translate risk and business goals into a right-sized plan and work across a portfolio of engagements rather than being embedded in one client.

You will lead assessment and enablement engagements, define project-level regulatory strategy, own quality agreements, and collaborate with delivery managers to align scope, budget, and timeline while