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Regulatory Compliance Specialist

2 weeks ago

Singapore beBeeRegulatory Full time
Regulatory Affairs Expert

We are seeking a skilled Regulatory Affairs Expert to play a crucial role in supporting the product lifecycle through obsolescence. This involves assessing changes made to the device post-launch to determine the regulatory impact of these changes on the current clearance.

Your Key Responsibilities:
  • Ensure regulatory compliance by conducting thorough assessments and submitting necessary documentation for product clearances and approvals from regulatory bodies such as the FDA, Notified Bodies, and others.
  • Contribute to the development and updating of regulatory strategy for new product development both domestically and internationally.
  • Develop and apply basic knowledge of regulatory frameworks, requirements, legislation, processes, and procedures.
Required Skills and Qualifications:
  • Bachelor's or Master's degree in Regulatory Affairs, Engineering, or a related discipline.
  • A minimum of 3 to 5 years of experience in a similar position within an R&D environment.
  • Experience in post-market activities and change management will be advantageous.
  • Possessing a Regulatory Affairs Certification (RAC) is also preferred.
About this Opportunity:

This position offers you the opportunity to contribute to regulatory compliance and strategy in a dynamic environment. Your role will involve critical decision-making, collaboration with stakeholders, and ensuring adherence to regulatory requirements throughout the product lifecycle.

You will be working closely with senior staff and have some independence in making decisions. You will also have the opportunity to develop and review Standard Operating Procedures (SOPs) and regulatory strategies based on changes in regulations.

In addition, you will provide regulatory input for new product development and product lifecycle planning. You will evaluate the regulatory impact of proposed changes to launched products and investigate regulatory history in relevant contexts.