Regional Regulatory Affairs, APAC (Imaging Diagnostics)

Permanent Position
30 May 2017
Expires on 13 Jun 2017

Company Description

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.

Posted by

Kelvin PANG Yu Kiu (Reg No: R1325516)

Tel

+65 9712 3229

Email

Job Description

  • 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

Requirements

  • 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  
  • Team Player 
  • 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
  • Impressive skills of people management

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