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Regulatory Affairs Associate (Medical Device)

Singapore
Manufacturing & Supply Chain
Permanent

Responsibilities

  • 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.

Requirements

  • 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)

jocelyn.ho@searchasia.com.sg

Consultant | EA Reg No:
Jocelyn Ho Wen Mun | R1658156