Quality Assurance and Regulatory Affairs Associate
2 weeks ago
**Responsibilities**
Quality Assurance:
- Overall implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 13485 and 21 CFR 820 standards.
- Ensure all departments carry out due processes and documentation required to ensure conformance to the QMS, including design & development, production and software.
- Conduct internal audits and lead external audit preparations.
- Conduct Management Review, onboarding training for new employees, and company-wide refresher training
- Collaborate with cross-functional teams to address non-conformances, CAPAs, and continuous improvement initiatives.
- Participate in risk analysis and management activities to ensure compliance with ISO 14971.
- Support post-market surveillance and vigilance reporting activities.
Regulatory Affairs:
- Preparation, submission, and maintenance of regulatory documentation for market approvals in regions including Singapore, US, Malaysia, and Australia.
- Monitor and interpret regulatory updates and standards relevant to medical devices.
- Ensure labeling, packaging, and promotional materials comply with regulatory requirements.
- Collaborate with the R&D and manufacturing teams to ensure product compliance during development and production phases.
- Maintain accurate and organized records to support regulatory inspections and audits.
**Minimum Skills and Requirements**
- Bachelor’s degree in Engineering, Science, or a related field.
- Ability to work independently and cross-functionally with different teams
- Strong organizational and analytical skills.
- Effective communication and teamwork abilities.
**Advantageous Skills**
- Knowledge or experience with regulatory submissions to Malaysia MDA, Australia TGA, US FDA, and Singapore HSA.
- Familiarity with ISO 13485, ISO 14971, and other relevant standards.
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