Specialist, Regulatory Affairs

Key Job Purpose:

• 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 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 to remain in compliance with the government regulatory requirements in Asia Pacific

Job Description:

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
• Notify and update Health Sciences Authority (HSA) of any change of particulars / documents related to product registration
• Ensure changes to the approved products and other relevant licenses are timely submitted to authorities as required
• Maintain product approvals and licenses, including dealers license 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 Sharepoint 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 including GN application.

Product Registration (Regional)

• Assisting the AP affiliates & distributors in data/information gathering from manufacturers, drafting/assisting in preparation of initial dossier for submission
• Maintain product registration record and product registration database to ensure proper documentation and record filing for all affiliates and business partner countries
• Maintain the knowledge and awareness of current applicable regulations and standards in AP region that impact the company’s compliance and align this with affiliates and business partner RA
• Support RA Manager in formulating regulatory plan / strategy for timely introduction of new products in AP region
• Support business partners in new product registration, renewals, re-registration and amendments
• Assisting in information coordination for AE & FSCA reporting in affiliates/distributors countries.
• Provide mentorship to affiliates RA and distributors if needed.

Job Requirements:

• Bachelor's degree in Medical Science or a related discipline.
• Minimum of 3 years' experience in a regulatory affairs role within the medical device or healthcare industry.
• Good understanding of medical device regulatory frameworks across the Asia-Pacific (APAC) region.
• Proficient in Microsoft Office applications and other standard business software (e.g. Power PDF).
• Customer-oriented with strong interpersonal and teamwork skills.
• Responsible, adaptable, and able to work effectively in a dynamic environment.
• Strong organisational skills with the ability to manage multiple priorities and meet deadlines.
• Excellent written and verbal communication skills in English.