Regulatory Affairs Specialist (Medical Devices / Pharma)

Job Summary We are looking for a Regulatory Affairs Specialist to support regulatory activities for marketed and new products within the local market. This role will work closely with Global Regulatory Affairs, cross-functional stakeholders and relevant Health Authorities to ensure timely submissions, regulatory compliance and product lifecycle management. Location: One-North Duration: 1-year Salary: Basic + 1 month bonus  Key Responsibilities Support the development and execution of regulatory strategies and plans for new and marketed products. Prepare and support regulatory submissions and dossiers in accordance with local regulatory requirements. Coordinate timely submissions, approvals and post-approval regulatory activities. Maintain product and establishment licences , including marketing authorisations and import licences, to ensure business continuity. Maintain accurate and audit-ready regulatory records and databases, including Veeva RIM . Monitor changes in regulatory requirements and conduct regulatory impact and gap assessments where required. Support updates to internal regulatory policies, procedures and documentation. Liaise with internal stakeholders and support communications and interactions with Health Authorities . Review local labelling, advertising and promotional materials to ensure compliance with applicable regulatory requirements and company standards. Provide regulatory support for market actions , including FSCAs, recalls and related Health Authority communications. Respond to regulatory queries from internal and cross-functional stakeholders in a timely manner. Support continuous improvement initiatives and contribute towards regulatory operational excellence. Perform other regulatory duties as required by the regional or local QRA team. Requirements Bachelor’s Degree in a Scientific, Engineering or related discipline. Good knowledge of ISO 13485 and applicable local regulatory requirements. By submitting your resume, you consent to the collection, use, and disclosure of your personal information per ScienTec ‘s Privacy Policy (scientecconsulting.com/privacy-policy). This authorizes us to: Contact you about potential opportunities. Delete personal data as it is not required at this application stage. All applications will be processed with strict confidence. Only shortlisted candidates will be contacted. Lua Zhi Chin (Jeanette) - R1873831 ScienTec Consulting Pte Ltd – 11C5781