Senior/ Engineer, Quality & Regulatory - Medical Devices (Healthcare)
Full-time
Senior Executive
2 months ago
What you'll be doingSupport risk management activities for medical device and development projectsAssist in implementing and maintaining Quality Manag.....
What you'll be doing
Support risk management activities for medical device and development projects
Assist in implementing and maintaining Quality Management Systems aligned with ISO 13485, ISO 14971, and IEC 62304
Prepare and maintain Design History Files and technical documentation
Collaborate with clinicians and engineering teams to validate requirements and support product de-risking
Provide day-to-day quality and regulatory support across project lifecycles
Track project milestones and support coordination across stakeholders
Contribute to technical reports, grant submissions, and innovation initiatives
Maintain organised, audit-ready documentation and records
What we're looking for
Bachelor Degree in Engineering/ Biomedical Engineering/ Science or related studies
2 – 4 years of working experience in quality and regulated environments within the medical device industry
Familiarity with ISO 13485, ISO 14971, IEC 62304, or similar standards
Strong technical writing, analytical thinking, and communication skills
Exposure to medical devices, healthcare, or regulated product development is advantageous
Audit exposure or understanding of software development lifecycle is a plus
Interested applicants, kindly furnish us with your full and detailed resume in MS Words format and click "Apply Now" button.
We regret to inform only shortlisted candidates will be notified. Applicants who do not possess necessary experience or qualification will still be considered on individual merits and may be contacted for other opportunities.
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