Regulatory Affairs Specialist, ASEAN

Job Title: Regulatory Affairs Specialist, ASEAN
Contract Type: Permanent
Location: Singapore
Salary: Competitive package
Start Date: 2019-10-03
Reference: BH-157869
Contact Name: Joanne Koo
Contact Email:
Job Published: October 04, 2019 14:25

Job Description

Regulatory Affairs Specialist, ASEAN
  • Single contributor
  • Reports to RA Manager
  • Based in Singapore
  • 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
  • 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