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Regulatory Affairs Associate (Medical Device)
Manufacturing & Supply Chain
- Compile and manage regulatory submissions in APAC region: process registration of new products, change notifications and renewals with the relevant authorities, as well as keeping close track of the registration status.
- Support reimbursements, tenders as required by Commercial.
- Coordinate with Commercial, principal product providers, distributors and regulatory consultants abroad to achieve timely application submissions and approvals.
- Provide regulatory submission strategies for new products and assess the regulatory impact of product / process changes to RA Manager.
- Provide regulatory approval matrix to Commercial periodically to ensure awareness of products registered.
- Keep abreast of the regulatory changes or trends in APAC countries and ensure compliance.
- Feedback to Project RA on APAC requirements for product / process changes, if applicable.
- Work proactively with other teams on the implementation of country specific labelling, product rework, allowable variations in APAC region.
- Maintain registration database, SAP Licence Master and SAP approval table for changes.
- Provides recommendations on reportability of adverse events.
- Provide feedback on FSCA, FSCA strategy and FSN and ensures regulatory obligations on post-market reporting.
- Follow up on product post-approval commitments to authorities.
- Support other Regional RA registration team on Free Sale Certificates and other documents required for product registration. Includes legalization and notarization of documents.
- Manage administrative duties as well as ad-hoc projects assigned by immediate superior.
- A relevant degree with more than 6 years of Regulatory Affairs experience.
- Knowledge in regulatory requirements of Class III medical devices and / or drugs in APAC.
- Working knowledge and experience dealing with competent authorities.
- Experience in compiling packages or dossiers in the countries' format, e.g. STED format, CSDT format
- Understands how product registration priorities interface with business strategies.
Jocelyn Ho Wen Mun (R1658156)
Consultant | EA Reg No:
Jocelyn Ho Wen Mun | R1658156