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Regional Regulatory Affairs Manager, ASEAN | Dental MNC

Job details

Location: Singapore
Job Type: Permanent
Discipline:
Reference: HCLS/EP/RRAMS/08061
Posted: 5 months ago
Consultant: Ewen Poh
Consultant Email: email Ewen
Consultant Phone: +65 6950 0365

Job description

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.

 

This job has expired!