Director, Quality & Regulatory Affairs

PulseMedica; Hamilton; On-site; CAD 140,000 - 210,000; Full time

Job summary

Moonrise Medical is seeking an experienced Quality leader with regulatory expertise to own quality across the full medical-device lifecycle, from development and design controls to manufacturing readiness and post-market activities, for an early-stage company in Canada.

You will partner across engineering, software, clinical, regulatory, and operations to drive strategy and hands-on execution, ensure FDA submissions readiness, and build a scalable quality system that supports growth.

Qualifications

• 10+ years of medical-device Quality experience with regulatory exposure.
• Hands-on design controls, DHFs, risk management, and traceability.
• Strong knowledge of FDA requirements and ISO 13485.
• Experience with electromechanical devices incorporating software.
• Proven ability to lead cross-functional quality activities in startups.

Responsibilities

• Lead Quality across the full medical-device product lifecycle.
• Own design controls and Design History File activities.
• Partner with cross-functional teams on user needs, design inputs/outputs, requirements, specifications, and traceability.
• Lead product risk-management activities.
• Lead Quality activities for verification and validation, including review of protocols, reports, test methods, and evidence.
• Lead Quality participation in design reviews and product changes.
• Collaborate with engineering, software, clinical, and product teams to integrate Quality throughout development.
• Lead or substantially contribute to regulatory submissions and readiness.

Skills

Quality leadership

Regulatory expertise

Design controls & DHF

Risk management

FDA 510(k) experience

ISO 13485 knowledge

Software in medical devices

Cross-functional collaboration

Startup/early-stage experience

Job description

About Moonrise Medical

Moonrise Medical is an early-stage medical technology company developing innovative solutions for vascular assessment. Our multidisciplinary team brings together expertise in medical devices, vascular medicine, ultrasound, engineering, and software.

We are seeking an experienced quality leader with strong regulatory experience to lead our quality function across the full medical-device lifecycle - from product development and regulatory clearance through design transfer, manufacturing, and commercialization.

The Role

This is a hands-on leadership role with responsibility for Quality across the full product lifecycle.

The role spans product development, design controls, verification and validation, risk management, regulatory readiness, design transfer, supplier and manufacturing quality, commercialization, and post-market activities.

You will also contribute to regulatory strategy and submissions, working with external regulatory expertise as appropriate.

We are looking for someone who can provide strategic direction, lead cross-functional activities, and remain actively involved in execution.

Responsibilities

Product Development & Quality

• Lead Quality across the medical-device product lifecycle.
• Own design controls and Design History File activities.
• Partner with cross-functional teams on user needs, design inputs and outputs, requirements, specifications, and traceability.
• Lead product risk-management activities.
• Lead Quality activities for verification and validation, including review of protocols, reports, test methods, and supporting evidence.
• Lead Quality participation in design reviews and product changes.
• Work closely with engineering, software, clinical, and product teams to integrate Quality throughout product development.

Regulatory

• Lead or substantially contribute to FDA 510(k) submissions and related regulatory activities.
• Contribute to regulatory strategy, applicable standards, testing requirements, and supporting evidence.
• Coordinate with external regulatory experts as appropriate.
• Support FDA interactions and responses to regulatory questions.

Quality Systems & Commercialization

• Own and continuously improve the Quality Management System, including document and change control, training, CAPA, nonconformance, audits, and management review.
• Lead Quality through design transfer and manufacturing readiness.
• Develop and oversee supplier qualification and supplier-quality activities.
• Partner with contract manufacturers to establish and maintain appropriate manufacturing quality controls.
• Lead complaint handling, post-market quality, and other commercial quality activities.
• Build the quality processes and capabilities needed to support the company's growth.

Qualifications

Required

• 10+ years of medical-device Quality experience, with meaningful Regulatory experience.
• Deep hands-on experience with design controls, DHFs, risk management, requirements traceability, and verification and validation.
• Strong knowledge of FDA medical-device requirements and ISO 13485.
• Experience with electromechanical medical devices incorporating software.
• Strong understanding of medical-device software quality and software lifecycle requirements.
• Direct experience supporting medical devices through FDA 510(k) submission and clearance.
• Experience taking a medical device from development through design transfer and commercial launch.
• Experience with manufacturing quality and supplier quality.
• Experience in an early-stage or startup medical-device company.
• Demonstrated ability to lead cross-functional quality activities while remaining a hands-on contributor.

Preferred

• Experience owning or substantially authoring FDA 510(k) submissions.
• Experience with ISO 14971, IEC 62304, and IEC 60601.
• Experience with diagnostic or imaging medical devices.
• Experience working with contract manufacturers.
• Direct experience interacting with FDA.

Who We're Looking For

You are an experienced Quality leader who understands the full medical-device lifecycle and brings strong Regulatory experience.

You are comfortable moving between strategic leadership and detailed execution and working across engineering, software, clinical, manufacturing, and regulatory functions.

You know how to identify priorities, make sound decisions, and drive complex activities to completion. You are pragmatic, collaborative, and take ownership.

Why Moonrise

This is an opportunity to lead Quality across the full lifecycle at an early-stage medical-device company. You will work closely with company leadership and an experienced multidisciplinary team, helping advance new medical technology from development through commercialization and beyond.