Hecal Pte Ltd

RA Executive (Medical Device / Philippines)

Hecal Pte Ltd | Date Posted: 13-Oct-2018
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Job Nature:
Permanent
Position Level:
Entry Level, Experienced
Qualification:
Bachelor's / Honours, Masters / PhD

Job Description

 

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

 

The Job:

  • Assist the company to setup the regulatory affairs in Philippines
  • Ensure all company products are in compliance with regulations in Philippines
  • Prepare, review and submit registration dossiers for new/extension, and changes in products
  • 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 internal and external audits activities, and support compliance with any follow ups
  • Collaborate cross functionally 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 1 years RA/QA experience in medical diagnostic equipment, pharmaceutical, medical device distribution or manufacturing environment
  • Familiar with FDA Philippines' regulations and processes as well as international standards like US FDA Quality System Regulations and cGMP, European Medical Devices, ISO 13485 Quality systems, etc.
  • Able to communicate (speak and write) with counterparts and authorities in Philippines using its native language
  • Able to travel overseas for job assignments for up to 30% yearly
  • Able to relocate back to Philippines permanently

 

Interested applicants, please email us your detailed resume in MS Words format. Only shortlisted candidates will be contacted.

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

Company Overview
Hecal Pte Ltd