Specialist, Regulatory Affairs

Key Job Purpose:

• Dossier preparation & product registration submissions 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 SAP affiliates & distributors including progress monitoring & follow-ups.
• Provide regulatory support, update, advisory & knowledge sharing to S-Corp, 3rd party manufacturers & other manufacturers and to Sysmex affiliates & distributors in order to remain in compliance with the government regulatory requirements in Asia Pacific.

Job Responsibilities:

1. Product Registration (Local):

• 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
• Review and edit dossier to comply with regulatory requirements
• Notify and update Health Sciences Authority (HSA) of any change of particulars / documents related to product registration
• Ensure changes to the approved products are timely submitted to authorities as required
• Ensure and maintain product approvals and licenses, including dealers etc. where applicable
• Manage Adverse Event and Field Safety Corrective Action reporting to HSA within the stipulated timeline
• Maintain product registration record and product registration database in iConnect to ensure proper documentation and record filing
• Maintain registration information in RA modules in S4& GTS and perform regulatory assessment and clearance to order blockage related to regulatory matters.
• Maintain the knowledge and awareness of current applicable regulations and standards and industry guidance in Singapore that impact the company's compliance
• Support business partners in new product registration, re-registration, renewal and amendment
• Support Sales, Marketing and SCM in all regulatory related areas
• Assisting the operational tasks as required

2. Product Registration (Regional)

• Assisting the AP affiliates & distributors in data/information gathering from manufacturers, drafting/assisting in preparation of initial dossiers for submission
• Maintain product registration records and product registration databases to ensure proper documentation and record filing for all affiliates and business partners countries
• Maintain the knowledge and awareness of current applicable regulations and standards for all affiliates and business partner countries
• Support business partners in new product registration, renewals and amendments
• Support Sales & Marketing and SCM in all regulatory related areas
• Assisting the operational tasks as required

Job Requirements:

• BSc in Medical Science or equivalent
• Min 1 years' experience in regulatory affairs including regulation research, technical documents creation and regulatory submissions.
• Medical Device Act & other medical device related regulations in Asia Pacific countries
• Fluent in English
• Knowledge of major IVD regulations/standards, at least IVD-R, ISO13485, MDSAP
• Basic computer knowledge & application, e.g. Microsoft Office, Power PDF, etc