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.