This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Lead Auditor - Contractor role based in Ireland.
This is an opportunity for an experienced medical device auditor to support the assessment of innovative health technologies and help ensure compliance with the highest regulatory standards.
The role focuses on conducting independent Quality Management System audits for companies developing advanced medical devices.
You will work with a flexible contractor model, delivering remote audits while applying your expertise in ISO 13485, EU MDR, and UK MDR requirements.
The position offers the chance to contribute to faster access to safe and effective healthcare innovations.
You will collaborate within a quality-focused environment where regulatory expertise, consistency, and independent judgement are highly valued.
This role is ideal for auditors who enjoy autonomy while contributing to a growing and impactful healthtech ecosystem.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Lead Auditor - Contractor role based in Ireland.
This is an opportunity for an experienced medical device auditor to support the assessment of innovative health technologies and help ensure compliance with the highest regulatory standards.
The role focuses on conducting independent Quality Management System audits for companies developing advanced medical devices.
You will work with a flexible contractor model, delivering remote audits while applying your expertise in ISO 13485, EU MDR, and UK MDR requirements.
The position offers the chance to contribute to faster access to safe and effective healthcare innovations.
You will collaborate within a quality-focused environment where regulatory expertise, consistency, and independent judgement are highly valued.
This role is ideal for auditors who enjoy autonomy while contributing to a growing and impactful healthtech ecosystem.
Accountabilities:
- Conduct remote audits of medical device manufacturers’ Quality Management Systems in accordance with ISO 13485, EU MDR, and UK MDR requirements.
- Review objective evidence, identify findings, and provide structured, accurate audit reports with clear conclusions.
- Ensure audit activities follow established methodologies, quality expectations, and regulatory principles.
- Deliver consistent and professional audit experiences while supporting the continuous improvement of audit processes.
- Apply sound regulatory judgement when interpreting requirements and evaluating compliance.
- Bachelor’s degree in a relevant scientific or engineering discipline, such as software engineering, computer science, physics, biophysics, biology, microbiology, chemistry, biochemistry, electrical/electronic/mechanical engineering, bioengineering, human physiology, medicine, or pharmacy.
- Minimum 4 years of professional experience within the medical device industry.
- Minimum 2 years of experience auditing or managing Quality Management Systems according to ISO 13485 and EU MDR and/or UK MDR.
- Previous experience working as a Lead Auditor with notified bodies or accreditation bodies.
- Strong understanding of medical device regulations, quality systems, and relevant standards, including ISO 14971, IEC 62304, IEC 82304, and cybersecurity requirements.
- Experience with software medical devices (SaMD) is strongly preferred.
- Strong communication skills with the ability to explain findings and regulatory expectations clearly and constructively.
- High level of independence, reliability, and attention to detail when managing audit assignments.
- Ability and willingness to adopt structured audit methodologies, tools, and quality-focused practices.
- Flexible contractor engagement model designed around audit demand and availability.
- Fully remote working environment.
- Opportunity to contribute to the evaluation of innovative medical technologies.
- Autonomy in managing audit assignments while collaborating with a quality-driven team.
- Exposure to advanced medical device companies and emerging healthtech solutions.
- Opportunity to apply and expand regulatory expertise in a fast-growing sector.
As a Lead Auditor, you will be responsible for independently delivering high-quality audits while ensuring regulatory compliance and maintaining consistent audit standards. You will assess medical device manufacturers’ Quality Management Systems, provide clear documentation, and support reliable regulatory outcomes.
Requirements:
The ideal candidate is an experienced medical device auditor with strong regulatory knowledge, technical expertise, and the ability to operate independently in a remote contractor environment.