Senior Quality & Regulatory Engineer

Senior Quality & Regulatory Engineer

Endiatx, Inc. | Hayward, CA | Full-Time

About Endiatx

Endiatx is a medical technology company developing next-generation medical robotic systems for gastrointestinal applications. Our team is building innovative diagnostic and interventional technologies designed to expand how physicians visualize, navigate, and interact with the GI tract.We are a hands-on, multidisciplinary team working across robotics, medical devices, imaging, software, manufacturing, clinical development, and regulatory affairs. As we advance our products through regulatory submission and toward commercialization, we are continuing to build the Quality and operational infrastructure needed to support the next stage of the company.

The Role

The Senior Quality & Regulatory Engineer will serve as a primary day-to-day resource across Quality Engineering and Regulatory Affairs. This individual will work closely with Engineering, Manufacturing, Operations and Clinical teams to ensure that product development and manufacturing activities are appropriately controlled, documented, and aligned with regulatory requirements.

On the Quality side, this role will provide technical leadership across design controls, risk management, verification and validation, Quality Systems, CAPA, supplier Quality, manufacturing Quality, and audit readiness. On the Regulatory side, the individual will help develop regulatory strategies, prepare and manage submissions, coordinate responses to regulatory agencies, assess product changes for regulatory impact, and ensure development programs generate the evidence needed to support future submissions.

The ideal candidate can independently lead routine Quality and Regulatory activities, recognize gaps early, coordinate subject-matter experts when needed, and appropriately escalate significant issues to executive leadership.

Key Responsibilities

• Serve as a senior Quality and Regulatory partner to Engineering, Manufacturing, Operations, Clinical, and company leadership throughout product development and commercialization.
• Provide Quality oversight of design controls, risk management, verification and validation, software documentation, manufacturing controls, supplier Quality, and product changes.
• Review technical documentation for completeness, traceability, compliance, and regulatory readiness, including Design History File / Design Development File documentation and submission-supporting evidence.
• Lead or support regulatory strategy for new products, product changes, indications, and future product generations, translating regulatory requirements into clear engineering, testing, documentation, and project actions.
• Prepare, coordinate, review, and maintain regulatory submissions, including 510(k)s and other FDA submissions as appropriate, and support responses to agency questions and requests for additional information.
• Assess design, software, manufacturing, labeling, and supplier changes for Quality and regulatory impact and ensure appropriate documentation, verification, validation, and regulatory pathways are addressed.
• Lead or oversee CAPA, nonconformance, deviation, complaint, and Quality investigations as applicable, including root-cause analysis, corrective actions, and evaluation of product or regulatory impact.
• Own and continuously improve key elements of the Quality Management System while providing technical oversight to junior Quality personnel performing routine eQMS, document-control, training, and records administration.
• Lead or support internal audits, supplier audits, FDA inspection readiness, ISO audits, and other external Quality or regulatory assessments.
• Support labeling and promotional-material review for consistency with cleared or approved indications and applicable regulatory requirements.
• Monitor relevant changes in regulations, standards, and FDA expectations; assess impact to company products and development programs; and coordinate external consultants, test laboratories, and certification partners as needed.
• Mentor junior Quality and Regulatory personnel and help establish scalable internal processes as the organization grows.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or a related technical discipline.
• Approximately 6+ years of medical-device Quality and/or Regulatory Affairs experience, with demonstrated depth across both technical Quality and regulatory activities.
• Strong knowledge of FDA medical-device requirements and ISO 13485.
• Strong experience with medical-device Design Controls, risk management, verification and validation, and change control.
• Experience supporting or preparing FDA submissions and interactions.
• Experience assessing design or manufacturing changes for Quality and regulatory impact.
• Experience with CAPA, nonconformance investigations, supplier Quality, manufacturing Quality, and audit readiness.
• Ability to review complex technical documentation and determine whether supporting evidence is sufficient for both Quality and regulatory purposes.
• Ability to translate regulatory requirements into practical actions for Engineering and Manufacturing teams.
• Strong technical writing, project coordination, and written and verbal communication skills.
• Ability to independently manage multiple priorities in a fast-moving medical-device startup environment.

Preferred Qualifications

• Experience with Class II medical devices and FDA 510(k) submissions.
• Experience developing or contributing to regulatory strategy for novel medical devices and supporting FDA Pre-Submission or other formal FDA interactions.
• Experience with complex electromechanical, robotic, imaging, endoscopic, or software-containing medical devices.
• Familiarity with ISO 14971, IEC 62304, IEC 60601, IEC 62366, ISO 10993, cybersecurity requirements, and other medical-device standards.
• Experience participating in FDA inspections, ISO 13485 audits, and supplier audits.
• Experience with eQMS platforms.
• Experience mentoring junior Quality or Regulatory personnel is preferred.

Location

On-site in Hayward, CA, Limited hybrid flexibility.

Compensation

$ 135,000 – $ 175,000 base salary, plus equity and benefits.

Work Authorization

Must be authorized to work in the U.S.

Equal Opportunity

Endiatx is an equal opportunity employer.

Accommodations

Reasonable accommodations provided.

Employment Status

At-will employment.

Pay: $135,000.00 - $175,000.00 per year

Application Question(s):

• Do you have a Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or a related technical discipline?

Education:

• Bachelor's (Required)

Experience:

• medical-device Quality and/or Regulatory Affairs: 6 years (Required)
• FDA medical-device requirements and ISO 13485: 3 years (Required)
• Design Controls, risk management, V&V, and change control: 3 years (Required)
• supporting or preparing FDA submissions and interactions: 3 years (Required)
• assessing design changes for Quality and regulatory impact: 3 years (Required)
• CAPA, nonconformance investigations, and supplier Quality: 3 years (Required)
• manufacturing Quality and audit readiness.: 3 years (Required)

Work Location: In person