Senior Regulatory Affairs Executive

16 hours ago

Singapore BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE. LTD. Full time

**Job Summary**

To support product registration in APAC region and technical documentation for pre-market submission and post-market obligations, as well as managing administrative work for RA department

**Responsibilities**:

- Compile and manage regulatory submissions for the assigned country/area 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.
- 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 SEA 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, GDP/GDPMD /GMP Certification, 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.

**Job Requirements**
- A relevant degree with more than 3 years of Regulatory Affairs experience.
- Knowledge in regulatory requirements of Class III medical devices in SEA or APAC region.
- Working knowledge and experience dealing with competent authorities.
- Experience in compiling packages or dossiers in the countries' format, e.g. STED format, CSDT format
- Meticulous organizational, planning skills and effective communication skills.
- Excellent English speaking and writing skills. Other Asian languages are an asset.
- Understands how product registration priorities interface with business strategies.
- Creative and critical thinking skills to solve ambiguous issues.

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