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Job Details

Location
Singapore
Salary
Competitive
Job Type
Permanent
Ref
BH-159269
Contact
Anissa Low
Posted
about 1 month ago

Our client is a global medical device company and leader in new product developemnt and medical education in Orthopaedics.


PURPOSE


Responsible for regulatory affairs activities for ASEAN, Hong Kong and Taiwan (countries to be assigned RA Group); manages the daily operations of regulatory affairs and assures regulatory submission compliance for submissions.  Maintains understanding and compliance requirements of regulatory affairs affecting company operations and products. Generates and manages submission documents for new products or changes to existing regulatory submissions. Responsible for designing, implementing, and maintaining an effective database system.   Reports the performance of the quality system to relevant authorities and the Management as required.

 

JOB RESPONSIBILITIES

  • Manage the process for registering and obtaining regulatory approvals for new/extension and change products with sufficient lead time for market introduction.  Ensure all regulatory compliance, submission, and approvals are met
  • Prepare regulatory filings for distributors of assigned countries
  • Establish information management system for regulatory affairs ensuring accuracy and completeness as well as document security
  • Regularly maintain and update product registration and listing databases for the assigned country
  • Collaborates cross – functionally with other departments and external resources including regulatory references and for contribution to completion of regulatory filings.  Corporate liaison between Singapore and RA team of distributors
  • Prioritize and organize multiples projects and competing priorities for efficient use of time
  • Identify global regulatory trends and their implications for assigned countries, taking into consideration the impact on business decisions
  • Analyze and communicate new or changing requirements and standards.  Develop strategies programs and processes to meet business objectives and ensure compliance with regulatory requirements
  • Participate in product safety alert/recall policy development and coordinates recalls
  • Review the product labelling and DFU, if any translation is required
  • Post market surveillance (complaint, PER, AE report, and/or any regulatory FDA body in the assigned country)
  • Participate in Quality System Audits by internal / external auditor
  • Maintain records of Medical Device operations licenses of the distributors for the assigned country
  • Initiate RA/QA related SOP
  • Serves as on-site quality management representative and liaison contact with regulatory officials on quality issues for Singapore as necessary
  • Responsible for Quality system documentation and quality approval process including maintenance of accurate and complete records and files
  • Responsible for issuance, distribution, and maintenance of training process relating to quality
 

Education and Experience

  • Bachelor’s Degree required, preferably in a Science or Engineering discipline
  • Training in technical aspects of regulatory affairs preferred
  • Industry background in medical device/Orthopedic preferred
  • At least 5 years or more working experiences
  • Strong interpersonal, oral and written communication skills required
 

Knowledge and Skill Requirements/Specialized Courses and/or Training

  • High degree of understanding of regulatory requirements, scientific methods, and engineering fundamentals
  • Ability to work in fast paced environment and handle multiple tasks and requests
  • Has gained comprehension of orthopaedic technical/engineering/medical terminology, or can reference literature for understanding
 


All CVs are to be sent to anissa.l.a4lmfvjwkch@ethosbc.aptrack.co for a confidential review.

License No. 16S8112
EA No. R1103376