Quality Governance: Own SOP lifecycle management and policy alignment with global standards. Embed risk-based compliance controls across business functions. Drive continuous improvement in quality systems and post-market surveillance.
Build strong distributor relationships to achieve regulatory timelines and enforce compliance standards. Act as senior escalation point for distributor compliance issues.
Responsible for all internal & external audits activities.
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Strategic Monitoring: Monitor the regulatory landscape for new requirements, assessing business impact and keeping Regional HQ informed of emerging trends.
Stakeholder Support: Act as a key regulatory advisor, supporting distributors and sales teams with technical product data.
System Management: Maintain and enhance the Quality Management System (QMS) in compliance with MFDS regulations and corporate policies. Lead internal training initiatives to foster a culture of quality.
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Build tools that make an impact: Maintain global regulatory database within our Document Management System, helping teams access critical information efficiently.
Shape the way we work: Research and co-create regulatory training materials, SOPs, and practical tools that drive consistency and improve how regulatory compliance and risk assessment processes are implemented across the organization.
A bachelor’s or master’s degree in food science and technology, Food Engineering or a related field is required.
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Cross-Border Compliance: Partner with Product, Compliance, and Risk teams to ensure business models and cross-border settlement flows align with local laws.
Commercial Support: Draft and negotiate regulatory-driven agreements, joint ventures, and strategic banking partner contracts.
Team Leadership & Mentorship: Manage and develop a small team of 1–2 junior legal counsel / legal specialists, assigning workflows, overseeing output, and supporting their professional growth.
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Provide guidance and recommendations to CASE Management and the ASAS Council on advertising-related matters, industry issues and regulatory developments.
Drive initiatives and projects to strengthen awareness, adoption and compliance with the SCAP.
Lead and oversee the review and resolution of advertisement-related complaints, feedback, enquiries and ad advice requests in accordance with SCAP and ASAS guidelines.
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Conduct investigations into quality incidents, including non-conformities, medication errors, and near-miss cases, and perform root cause analysis with appropriate report preparation.
Work closely with internal teams and relevant stakeholders to investigate quality issues, implement corrective actions, and ensure timely resolution.
Develop, review, and maintain SOPs, work instructions, and training materials to support regulatory compliance and operational effectiveness.
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Support quality processes, including CAPA management, cross-functional investigations, solution implementation, effectiveness verification, status reporting, escalation activities, process guidance, and Non-Product Software Validation.
Partner with cross-functional stakeholders to enhance QMS effectiveness and operational excellence, driving process standardization, continuous improvement initiatives, Kaizen events, and other related duties or ad hoc assignments as required.
Diploma or bachelor’s degree in engineering, Quality Assurance, or a related field, with a minimum of 3 years of experience in a manufacturing environment, preferably instrument manufacturing.
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