QARA Engineer (Quality Assurance & Regulatory Affairs)

Job Summary
We are seeking an experienced QARA Engineer with strong expertise in medical device quality systems and regulatory compliance. The candidate will support global MedTech customers in maintaining compliance with international standards and regulatory requirements while coordinating with global cross-functional teams.
Key Responsibilities
Support Quality Management System (QMS) activities aligned with ISO 13485 requirements
Participate in risk management activities as per ISO 14971
Support design control, CAPA, NC, complaint handling, and internal audits
Prepare and review technical documentation for regulatory submissions
Support product lifecycle management and regulatory compliance activities
Collaborate with global teams across USA and Ireland customers
Participate in supplier quality and audit support activities
Ensure compliance with FDA, EU MDR, and international medical device regulations
Support document control and change implementation activities
Required Skills & Experience
5–8 years of experience in Medical Device / MedTech industry
Strong knowledge of:
ISO 13485
ISO 14971
ISO 10993
FDA QSR / 21 CFR Part 820
EU MDR
Experience in CAPA, risk management, audit support, and quality systems
Strong communication and stakeholder management skills
Experience working with global cross-functional teams
Preferred Qualifications
Bachelor’s degree in Engineering / Biomedical / Life Sciences
Experience with Class II or Class III medical devices preferred
Regulatory submission exposure is an added advantage

Work arrangement
No