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Senior RA/QA Executive

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KARL STORZ

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Location:
Singapore , Singapore

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Responsibility:

  • Regulatory Submissions & Change Notification Governance: Coordinate and track timely submissions for product registrations, renewals, and variations across Asia. Own the end-to-end process for regulatory change notifications, ensuring impact assessments, documentation readiness, and submission tracking in partnership with country RAQA and global teams
  • Regulatory Intelligence, Labelling & UDI Compliance: With the support of local RAQA, monitor evolving Asia regulations and provide strategic insights on labelling and UDI requirements. Support impact assessments, update SOPs/templates, and disseminate regulatory intelligence to country teams to ensure compliance and traceability
  • Complaint Handling, FSCA & Recall Execution: Lead regional coordination of complaint intake, triage, and resolution. Manage FSCA and recall processes, ensuring timely execution, regulatory reporting, and effective field actions in collaboration with Quality, Supply Chain, and Commercial teams
  • Post-Market Surveillance (PMS) Strategy & Vigilance: Monitor and analyse PMS data trends to identify emerging risks. Lead regional input into global PMS reports, risk assessments, and vigilance submissions. Ensure compliance with local adverse event reporting and surveillance requirements
  • Data Management, Reporting & Transparency: Maintain dashboards and trackers for regulatory submissions, PMS, quality metrics, and compliance status across APAC markets. Provide regular reporting to regional and global stakeholders to support visibility and decision-making
  • Process Harmonization & Continuous Improvement: Drive harmonization of RA and PMS processes across Asia, aligning with global standards. Identify and implement process improvements to enhance efficiency, compliance, and visibility. Develop SOPs, templates, and governance tools to support consistent execution
  • Training, Capability Building: Develop and deliver training programs on regulatory change, vigilance, and PMS processes. Act as a regional resource for country RAQA teams, providing coaching and escalation support
  • Ad-Hoc Regional Support & Escalations: Serve as a flexible point of contact for subsidiary-level needs intersecting with regional objectives. Provide timely assistance for emerging projects, pilot programs, authority inquiries, and urgent compliance matters as directed by the Regional RAQA Director or global RAQA teams

Requirements:

  • Recognised Diploma/Degree in Life Sciences, Engineering, Regulatory or related field
  • 3-4 years of experience in RAQA within the medical device industry
  • Experience working in a regional or multi-country environment with cross-functional teams
  • Excellent organizational, analytical, and communication skills
  • Strong interpersonal and communication skills
  • Meticulous attention to details
  • Good time management skills are highly essential
What we offer:
  • Leave Benefits (Vacation Leave, Sick Leave, Parental Leave, etc.)
  • Birthday Benefits
  • Transport Allowance (if applicable to role)
  • Accessibility to Public Transport
  • Flexible Work Arrangements
  • Group Health Insurances
  • Flexi-Benefit Reimbursement
  • Wellness Programs and Activities
  • Professional Development Opportunities
  • Global Exposure & Business Travel Opportunities (if applicable to role)
  • All other statutory benefits

Additional Information:

Job Posted:
April 05, 2026

Work Type:
Hybrid work
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