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Our client's products make a difference every day. Our client is a health imaging and information technology solutions company. We provide medical and dental imaging systems and healthcare IT solutions and X-ray film and digital X-ray products for the non-destructive testing market worldwide.
Work closely with the Regulatory Affairs team to establish and implement corporate regulatory policies and procedures to assure compliance with applicable international regulations and standards
Work with internal regulatory resources, external distributors, and external consultants to obtain Ministry of Health agency product registration requirements
Provide guidance on Ministry of Health, Product Safety and Quality System requirements to obtain marketing approval for products
Assist in training on device regulations for medical and dental products
Prepare dossiers for product registrations/approvals
Maintain documentation system to assure all associates (regulatory, sales, marketing, etc.) have access to registration, license, permits, etc. documents as required for Ministry of Health registrations, sales and marketing support
Monitor and communicate changes to medical device products laws, standards, guidance, etc
Manage external services such as agencies and product test houses.
Monitor ASEAN regulations and requirements update and make sure regulatory compliance in those territories
Submit dossiers and provide Regulatory Affairs (RA) support/coordination for product registrations/approvals and ensure registrations in line with business time and cost requirements
To strongly support product registration in ASEAN countries
Answer questions and enquires from distributors, dealers and dentists for regulatory evidence requests
Provide leadership and guidance on regulatory compliance
Analyze and manage post market incident reporting activities
Manage internal and external QMS audits in ASEAN countries
Fluent English and language(s) for assigned territory
Experience of regulatory or registration leadership experience in assigned territory
Proven Project Management skills
Ability to provide accurate advice to all levels within the company
Knowledge of Lotus Notes, Access and good level of IT competence.
Excellent Interpersonal Skills and strong vital communication skills (e.g. telephone. Electronic media)
Demonstrated track record of developing organizational capability
Leadership in Driving Internal and external Processes
Must possess excellent communication
Ability to prioritize for maximum results (multi-task management)
Develop strategic goals and objectives from knowledge base and understanding of a customer’s business Familiar with the procedures of the Department of gynaecology and obstetrics is a plus
Strong ability for market analysis, make and develop sales strategy；Demonstrated good judgment and decision making capabilities