Senior/ Engineer, Quality & Regulatory - Medical Devices (Healthcare)

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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