Senior Quality and Regulatory Consultant

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

Senior Quality and Regulatory Consultant

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.

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.

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