Reporting to the Senior Manager, QA/RA, the successful candidate will be responsible for world-wide product registration and compliance to major international regulatory standards, specifically USA FDA QSR, 21 CFR pt 820, EU IVDD 98/79/EC for CE Marking, and China’s State Food & Drugs Administration (SFDA)
Preparation, submission of technical dossiers or technical files to regulatory authorities
Coordinate with internal staff and external parties to ensure timely submission and approval of product registration
Manage the overall global registration processes, field actions, adverse events reporting
Requirements:
Basic Science Degree with minimum 3 years’ regulatory experience in diagnostic test kits, pharmaceutical or medical device manufacturing environment
Trained in the following:
US FDA Quality System Regulations and cGMP
European Medical Device, IVDD Directives
ISO 13485 Quality Systems
Effective written and oral communication skills in English & Mandarin
Organized and meticulous
MP Biomedicals Asia Pacific Pte Ltd offers a competitive compensation and benefits package. Interested candidates are invited to apply in confidence stating full personal and career details, qualifications, present and expected remuneration together with a recent photo and a contact telephone number to:
Director, Human Resource
MP Biomedicals Asia Pacific Pte Ltd
2 Pioneer Place
Singapore 627885
E-mail: leechin.chong@mpbio.com
(Only shortlisted candidates will be notified)
