Senior Quality Regulatory Engineer
Job Summary
The Senior Quality & Regulatory Engineer supports risk management and compliance activities for medical device development projects. This role involves maintaining Quality Management Systems, preparing technical documentation, and collaborating with cross-functional teams to ensure product safety. The position requires experience in regulated medical device environments and familiarity with international quality standards.
Responsibilities
- Support risk management and compliance activities
- Maintain QMS per ISO 13485, ISO 14971, IEC 62304
- Manage Design History Files and technical docs
- Coordinate with engineering and clinical teams
- Track project milestones and regulatory documentation
Required Skills
- Bachelor’s degree in Engineering or Science
- 2-4 years experience in medical device quality
- Knowledge of ISO 13485, ISO 14971, IEC 62304
- Technical writing and analytical skills
- Software development lifecycle understanding
Job Details
### Responsibilities
- 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
### Requirements
- 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