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Regulatory Affairs Specialist, ASEAN

Job Details

Location
Singapore
Salary
Competitive package
Job Type
Permanent
Ref
BH-157869
Contact
Joanne Koo
Posted
about 1 year ago
Regulatory Affairs Specialist, ASEAN
  • Single contributor
  • Reports to RA Manager
  • Based in Singapore
 
JOB RESPONSIBILITIES
  • Provide regulatory support to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new or changed product launches
  • Prepare and maintain technical file / design dossier for CE marking Class IIa and III medical devices
  • Liaise with Global Regulatory Affairs team on technical files availability
  • Communicate the Medical Device Reporting and Vigilance Reporting in accordance with the local authorities’ regulatory requirement. Collaborate with the corporate office to conduct any local field safety corrective actions or product recalls.
  • Work closely with cross functional teams in achieving regulatory affairs initiatives to support business objectives
 
 
REQUIREMENTS
  • Bachelor's degree in Biomedical Science or Bioengineering or related studies
  • Preferably at least 2 years relevant experience in regulatory affairs with medical devices company
  • Strong written and oral communication, and technical writing skills
  • Good interpersonal skills

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