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28 Jul
2015
Full-Time Regulatory Affairs Consultant
Job Description
This position requires a very high level of autonomy to support Andaman Medical in achieving regulatory/quality goals and objectives.
The main responsibility is to proactively support the organization in achieving the necessary regulatory submissions needed for our clients and to develop and maintain worldwide regulatory knowledge. The regulatory affairs and quality assurance executive will also be responsible for developing and maintaining the organization Quality Management System.
Essential Job Functions
- Prepare submissions to the local and international health authorities for new product registration and/or new establishment licensing
- Follow-up input request from MDA or other agencies to ensure successful product registration and/or new establishment licensing
- Maintain company databases of regulatory approvals
- Serve as regulatory/quality consultant to our clients
- Implement and maintain the Quality Management System as per GDPMD requirements
- Manage Internal and External Audits
- Manage Post-Market surveillance activities
Requirements
Candidate must possess:
- Professional Degree, Biology, Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent.
- Fresh Graduates, no work experience needed as we will have trainings.
Other Skills/Abilities
- English, Bahasa Melayu, ALL SPOKEN AND WRITTEN
- Computer literate with advanced skills in Microsoft Office (Word, Excel, Powerpoint, etc…)
How to Apply
Contact Us To Learn More
Andaman Medical is always looking for talented, energetic people that are ready to advance in the medical device regulatory field. Feel free to contact us to learn more about exciting opportunities. If you are interested, please drop your resume at durga@andamanmed.com or call 04-2228849.1165 total views, 1 today
