RA Executive (Medical Device / Philippines)
Our Client is multinational manufacturer of high-technology devices and instruments.
- 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
- 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.
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