Executive -Regulatory Affairs

The Regulatory Affairs Associate is an integral part of the Quality and Regulatory team. The associate will be responsible for maintaining regulatory compliance via registrations, document control, being part of the internal and external audit team, analysing data, reporting trends, and coordinating CAPA facilitation. In addition, the associate will provide regulatory support to product development, quality, and production with respect to design, process, and quality concerns. Essential Functions/Skills:

• Communicates with regulatory authorities and/or distributors to prepare and submit documentation for marketing approval in ASEAN, Middle East and GCC Nations.
• Co-ordinates with distributors for Medical Device registration in other parts of the world as and when required.
• Performs research, distribution, storage, tracking, and retrieval of relevant information/documents pertinent to the regulatory registrations and submissions.
• Authors, reviews, and publishes paper and electronic submissions and communicates with regulatory authorities and government agencies.
• Provides regulatory information and guidance for proposed product claims/labelling.
• Identifies the need for new regulatory procedures, Operating Procedures, and participates in development and implementation.
• Helps train stakeholders on current and new quality and regulatory requirements to ensure organization-wide compliance.
• Assists other departments in the development of Operating Procedures to ensure regulatory compliance.
• Reviews proposed product changes for impact on regulatory status of the product.
• Prepare/record changes to controlled documents including formatting, review and confirm changes with relevant departments, prepare training material, and coordinate with users to ensure electronic document processing is complete and document control is maintained and effective.
• Performs other duties that are reasonably assigned.

Job Requirements: A Bachelors degree in a scientific discipline along with a minimum of 3 years regulatory affairs experience in a medical device environment is required. Comprehensive understanding of applicable regulations of ASEAN, Middle East and GCC Nations. The associate will be responsible for working with multiple departments, including Customer Service, Sales, Production, and Engineering.