Job Details

Competitive package
Job Type
Joanne Koo
Contact email
Email Joanne
Contact phone
65 6692 0751
4 months ago
Regulatory Affairs (Contractor)
  • Single contributor
  • 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 regulatory affairs activities; 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.  Responsible for designing, implementing, and maintaining an effective database system. 
  • 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 and submit regulatory filings with relevant authorities for products
  • Establish information management system for regulatory affairs ensuring accuracy and completeness as well as document security
  • Participate in the development and lifecycle management product to ensure compliance with all internal and external requirements for country assigned
  • Build a robust repository database to update and maintain all documents including technical files / submission dossiers as per applicable SOPs, and liaise with the relevant department / country as required
  • Contribute to the review and improvement of regulatory processes
  • 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