Head of Quality

Eyebot•Boston, MA

34d•Onsite

About The Position

Eyebot is seeking a Head of Quality to establish and lead the company's quality and regulatory functions. This role is crucial for scaling medical device operations in the US and preparing for international expansion, particularly in the European Union. The Head of Quality will collaborate with the engineering team to implement and maintain design controls, risk management, and verification/validation processes in compliance with FDA and international regulations. This is a full-time, onsite position based in Boston’s North End, requiring five days a week to foster 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.
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.

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.
Establish and maintain design controls, risk management, and verification and validation processes.
Own PMS, vigilance, and regulatory reporting processes.
Collaborate with engineering and operations in a fast-moving environment.