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Regional Regulatory Affairs Manager, ASEAN | Dental MNC

Responsibilities
• Continually develop, monitor and report on the metrics needed to gauge the performance of the ASEAN Quality System
• Responsible for registrations of new and existing products.
• Provides appropriate mentoring, appraisals, and discipline of direct reports
• Manage registration portfolio through daily management and track on-time delivery of registration projects
• Collaborate with dealers and local governments on registrations and registration maintenance
• Evaluate dealers and other third parties for capability to act on company behalf in local registrations
• Collaborating with operating companies on labeling translations
• Assessing impact of product design changes on local registrations
• Assist in the regulatory review of product labels, literature and websites
• Collaborate with operating companies on adverse effects reporting, field corrective actions
• Participates in audits and inspections of the company and its quality systems

Experience
• Minimum of Bachelor's Degree, higher education preferred.
• 5+ years’ experience working in medical device regulatory environment in the region
• Deep and current knowledge of Quality Management principles in a Commercial environment
• Fluent English both written and spoken

Please contact Ewen Poh at +65 6435 5616 or charterhousehealthcare@charterhouse.com.sg for a confidential discussion

EA License no: 16S8066 | Registration no: R1550486

Only successful candidates will be notified.
To apply, please email your CV to . If you would like further information, please contact Ewen Poh on +65 6435 5616 quoting HC&LS/EP/RRAMS/08061
or complete the Application form below.
Application for Regional Regulatory Affairs Manager, ASEAN | Dental MNC

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