Hecal Pte Ltd

Regulatory Affairs Executive (Medical Device)

Hecal Pte Ltd| Date Posted: 6-Sep-2020
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Job Nature:
Permanent
Position Level:
Entry Level, Experienced
Qualification:
Bachelor's / Honours

Job Description

Our Client is multinational manufacturer of high-technology devices and instruments.

 

  • Regulatory Affairs/Compliance matters in Medical Devices
  • Permanent / Full-Time, Junior position
  • Attractive Employee Benefits
  • 5-days working schedules

 

The Job:

  • Ensure all company products are in compliance with local regulations
  • Prepare, review and submit registration dossiers for new/extension, and changes in products for Singapore market
  • Liaise with local regulatory authority pertaining to registration and follow up with input requests from authorities until license obtained
  • Maintain regulatory database(s), review and revise SOPs regularly
  • Keep up-to-date with the developments in RA/QA and assist with implementation of any required revisions
  • Responsible for all GDPMDS internal and external audits activities, and support compliance with any follow-up
  • Collaborate cross functionality with other departments
  • Ensure timely post-market surveillance (customer complaints, adverse event, FSCA (including recall)) reporting until closure
  • Provide regulatory advice/input to internal and external stakeholders
  • Work closely with internal departments on related matters

 

The Candidate:

  • Degree in Bioengineering or Medical related disciplines
  • Min 3 years RA/QA experience in medical diagnostic equipment, pharmaceutical, medical device distribution or manufacturing environment
  • Familiar with international standards like US FDA Quality System Regulations and cGMP, European Medical Devices, ISO 13485 Quality systems, etc., as well as HSA regulations and processes
  • Able to travel to the Southwest/West of Singapore

 

 

Interested applicants are requested to apply online or email to [Click Here to Email Your Resume] their CV in WORDS document with photograph, current salary, notice period and reason for leaving. Only shortlisted applicants will be contacted.

 

Tan LK | EA Licence No. 12C6198 | EA Reg. No. R1111728

Company Overview
Hecal Pte Ltd