Job Description

Responsibilities Summary The Regulatory Affairs Executive will be responsible to support and provide guidance to countries in Greater Asia on activities related to EU MDR/IVDR program, operations initiatives, manufacturing plant, et Responsibilities Summary The Regulatory Affairs Executive will be responsible to support and provide guidance to countries in Greater Asia on activities related to EU MDR/IVDR program, operations initiatives, manufacturing plant, etc. Collaborate with various stakeholders such as the GA regional RA team, global and country RA counterparts and other functions to ensure business continuity. Job Function: This position will maintain the regional overview of the EU MDR/ IVDR impact to countries in Greater Asia and the overall country registration status. Will need to execute regulatory strategy / process / procedure to enhance partnership and cross-functional activities expedite market access & business growth etc. This is achieved by working with various BD affiliates / external parties and taking into considerations various aspects of regulations \' e.g. product registration, manufacturing requirements, country requirements on specific product type, etc. In the regional role, the Regulatory Affairs Executive will be required to facilitate / track the preparation and documentation for regulatory submissions as well as to support and provide assistance in ensuring prompt support from global RA. Work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors, including the variation in Regulatory requirements of the many regulated countries in Greater Asia. Key Responsibilities: Provide RA assistance and support on projects for the region. Facilitate/ track the preparation and submissions of regulatory documents, registration dossiers, licenses for manufacturing facility, etc. to support the projects. Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements.Participates as required in training on regulatory issues affecting own area of work. Complies with all local, state, federal, and BD safety regulations/policy/procedures. Performs other related duties and assignments as required Position Requirements: 3 plus years of experience in regulatory affairs and compliance in the Medical Device and/or Pharmaceutical Industry required. Hands-on experience as functional representative in projects and experience in working with a team of cross-departmental / cross-cultural individuals. Experience and knowledge in product registration of medical devices, In-Vitro Diagnostics or medicinal products in various Asian countries. Knowledge of the EU Medical Device & IVD Regulations.

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