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Quality Assurance and Regulatory Affairs Associate

1 month ago

Singapore PRECIX PRIVATE LIMITED Full time
Roles & Responsibilities

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.
Tell employers what skills you have

Excellent Communication Skills
Quality Assurance Management
Analytical Skills
Quality Management
Ability To Work Independently
Quality Assurance
Usability Engineering
Regulatory Affairs
ISO
Surveillance
Attention to Detail
Medical Devices
Audits
Regulatory Requirements
Electrical Safety
Team Work
Audit
Quality Assurance Processes