Roles & Responsibilities
What you'll be doing
- Implement and maintain quality management system processes across medical device innovation projects
- Provide regulatory and quality guidance to project teams, including validation of unmet clinical needs, risk assessments, and de-risking of proposed solutions
- Ensure compliance with quality standards, regulatory requirements, and organisational policies, supported by accurate documentation and record-keeping
- Support project execution by monitoring milestones, preparing technical documentation, and ensuring alignment with grant deliverables and KPIs
- Collaborate with cross-functional teams to strengthen risk and quality practices in the development of safe and effective medical technologies
What we're looking for
Masters / Bachelor Degree level in Engineering / Science2 - 4 years of relevant working experience preferably with hands-on in risk management processes and quality management systems for medical devicesKnowledge of ISO 13485, ISO 14971, IEC 62304; exposure to ISO 14155 and other medical device regulations / standards is an advantageExperience with quality implementation / maintenance and participation in ISO 13485 / IEC 62304 audits preferredFamiliarity with the software development lifecycle and technical project coordination / documentationStrong analytical, problem-solving, and technical writing skillsEffective communicator, team player, and highly detail-orientedInterested 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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JOBSTUDIO PTE LTD
EA License No : 10C4754
EA Personnel : Stephanie Toh
EA Personnel Reg No : R1217674
Tell employers what skills you have
Technical Documentation
Quality Management
Technical Writing
Quality Management Systems
Healthcare
ISO
Risk Management
Biomedical Engineering
Biology
Medical Devices
Audits
Project Coordination
Regulatory Requirements
Writing Skills
Commissioning
Technical Support