Job Details

Competitive package
Job Type
Joanne Koo
Contact email
Email Joanne
Contact phone
65 6692 0751
4 months ago
Regulatory Affairs/Quality Assurance Specialist
  • Single contributor
  • ASEAN + HK + TWN
  • Based in Singapore
Our client is a global medical device company and leader in new product development and medical education in orthopedics. They have pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year.


Responsible for all regulatory affairs activities for ASEAN, Hong Kong and Taiwan.  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 quality system.  Reports the performance of the quality system to relevant authorities and Company Management as required. 
  • Manage the process for registering and obtaining regulatory approvals for new/extension and change products with sufficient lead time for market introduction. Ensures all regulatory compliance, submission, and approvals are met
  • Prepare and submits regulatory filings with relevant authorities for products
  • Establish information management system for regulatory affairs ensuring accuracy and completeness as well as document security
  • Maintain product information databases. Also maintains registration and listing files – including interim and monthly/annual reports
  • Collaborate cross – functionally with other departments and external resources including regulatory references and for contribution to completion of regulatory filings. Corporate liaison between Singapore office and all regulatory bodies
  • 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 requirement
  • Participate in product safety alert/recall policy development and coordinates recalls
  • Review and approve product labelling, DFU
  • 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 Medical Device operations licenses for the assigned country
  • Initiate RA/QA related SOP
  • Serve as on-site quality management representative and liaison contact with regulatory officials on quality issues 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
  • Bachelor’s Degree; preferably in a Science or Engineering discipline
  • Relevant background in regulatory affairs; high degree of understanding of regulatory requirements, scientific methods, and engineering fundamentals
  • Previous industry experience in Orthopedic preferred; good understanding in orthopaedic technical/engineering/medical terminology, or can reference literature for understanding
  • Strong interpersonal, oral and written communication skills required
  • Ability to work in fast paced environment and handle multiple tasks and requests
  • Ability to define problems, collect data, establish facts, and draw valid conclusions
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables

Reg No. R1109555
EBC Connect Pte Ltd
Licence no. 17C8975