- Dossier preparation & product registration submission to HSA, leading to timely introduction of new products and responsible for supplemental filings for any changes
- Assisting in data/information gathering & dossier compilation for product registration submission & other related licenses for Sysmex Asia Pacific affiliates & distributors including progress monitoring & follow-ups.
- Provide regulatory support, update, advisory & knowledge sharing to Sysmex Corporation in Japan & Sysmex affiliates and distributors in order to remain in compliance with the government regulatory requirements in Asia Pacific.
Responsibilities
- Prepare & submit product registration documentation & other relevant licences’ application and ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements that lead to timely approval of new product registration in Singapore
- Notify and update Health Science Authority (HSA) of any change of particulars / documents related to product registration
- Manage adverse event and field safety corrective action reporting to HSA within the stipulated timeline
- Ensure changes to the approved products are timely submitted to HSA as required
- Maintain product approvals and dealer’s licences
- Maintain product registration record and product registration database to ensure proper documentation and record filing
- Maintain the knowledge and awareness of current applicable regulations and standards
- Support business partners in new product registration, renewals and amendments
- Support Sales, Marketing and Supply Chain Management in all regulatory related areas
Requirements
- Diploma in Medical Science or equivalent
- Min 6 months experience in regulatory affairs or 1 year in a science/technical role in the health care industry (R&D, Clinical or other technical function)
- Knowledge of Medical Device Regulation in Singapore and Asia Pacific
- Basic computer knowledge & application
- Customer focused with excellent communication and interpersonal skills
- Responsible, team player, keen to learn
- Ability to manage and prioritize multiple projects and tasks
- Travel requirement: up to 20% per year in Asia Pacific region
ALL APPLICATIONS WILL BE TREATED WITH THE STRICTEST CONFIDENTIALITY
We regret that only shortlisted candidates will be notified.