Director of Quality Assurance

3 weeks ago

Galway, Galway, Ireland SciPro Full time
Overview

Are you passionate about driving excellence in quality systems and regulatory compliance? This senior leadership role offers the opportunity to oversee and shape global quality and regulatory operations for an organization developing innovative medical technologies.

Director of Quality & Regulatory Affairs

As Director of Quality & Regulatory Affairs, you will set strategy, lead execution, and ensure that products meet the highest standards of safety, effectiveness, and compliance worldwide. This position requires a combination of strategic vision, technical expertise, and strong leadership, particularly in navigating U.S. and European regulatory frameworks.

Key Responsibilities
  • Define and direct the overall Quality & Regulatory strategy, aligning it with business objectives.
  • Lead regulatory submissions and maintain strong relationships with authorities in major markets.
  • Ensure compliance with medical device regulations including U.S. FDA, European MDR, and other applicable standards.
  • Oversee the implementation and continuous improvement of an ISO 13485-certified Quality Management System.
  • Ensure adherence to critical product standards, including IEC 62304 (software lifecycle) and IEC 60601 (electrical safety).
  • Manage audits, risk assessments, and corrective/preventive actions.
  • Collaborate with R&D, Clinical, and Operations teams to embed compliance throughout the product lifecycle.
  • Monitor regulatory changes worldwide and proactively adapt internal processes.
  • Mentor, develop, and inspire the QA/RA team to foster a culture of compliance and continuous improvement.
What You'll Bring
  • Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
  • Extensive experience in senior QA/RA roles within the medical device sector.
  • Demonstrated expertise with FDA submissions (510(k), PMA) and European MDR compliance.
  • Strong knowledge of IEC 62304, IEC 60601, ISO 14971, and ISO 13485.
  • Track record of successfully leading audits and managing quality systems.
  • Excellent communication, leadership, and organizational skills.
  • Ability to perform effectively in a fast-paced, innovation-driven environment.
Seniority level

Director

Employment type

Full-time

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing


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