Head of Quality

Eyebot • Boston, MA

1d • $150 - $220 • Onsite

About The Position

We are looking for a Head of Quality to build and lead Eyebot’s quality and regulatory function as we scale our medical device operations across the United States and prepare for expansion into the European Union. You'll work closely with the engineering team to establish and maintain design controls, risk management, and verification and validation processes that meet FDA and international regulatory requirements.
Note: This is a full-time, onsite role based in Boston’s North End. We work together five days a week to support rapid prototyping and cross-functional collaboration.

Requirements

• Deep experience with medical device quality systems.
• Strong understanding of FDA requirements, including 510k exempt pathways.
• Knowledge of EU MDR and international regulatory frameworks.
• Experience with QMS implementation and ISO 13485.
• Experience with risk management, design controls, CAPA, document control.
• Ability to collaborate with engineering and operations in a fast moving environment.
• Hands-on experience leading medical device certifications in one or more of the following regions: EU (MDR), UK (UKCA), Canada (Health Canada / MDSAP), Mexico (COFEPRIS).
• Demonstrated experience working directly with Notified Bodies and regulatory authorities.
• Strong working knowledge of EU MDR, including PRRC (Article 15) responsibilities.
• Experience owning PMS, vigilance, and regulatory reporting processes.

Nice To Haves

• Previous experience formally acting as a PRRC or equivalent regulatory accountability role.
• Experience supporting EU MDR Class IIa medical device certifications.
• Experience scaling quality and regulatory systems in a high-growth startup environment.
• Experience supporting or fulfilling MDR PRRC accountability requirements, including preparation and maintenance of MDR technical documentation and hands-on support of MDR CE certification activities with Notified Bodies.

Responsibilities

• Drive regulatory strategy and submissions for U.S. and international markets, including EU MDR, UKCA, and other global certifications, while maintaining ongoing compliance and reporting.
• Develop and lead Eyebot’s quality management system (QMS) to ensure compliance with FDA, ISO 13485, and international regulations.

Benefits

• Starting target salary in the range of 150k-220k, along with meaningful equity.
• Flexible work schedule with unlimited PTO.
• A culture where every idea is welcome, no matter how out there it sounds — that’s how Eyebot got started.
• Full health, dental, and vision insurance.
• Commuter support and wellness benefits.
• A collaborative office environment in Boston’s North End, with regular team lunches and a great waterfront location.
• The chance to build products that improve lives and redefine how vision care is delivered.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed