
Regulatory Compliance Specialist
7 hours ago
Regulatory Affairs plays a critical role in ensuring the compliance and strategy of products throughout their lifecycle.
As a Regulatory Affairs Specialist, you will be responsible for assessing changes made to products post-launch to determine the regulatory impact on current clearance.
Key responsibilities include:
- Conducting thorough assessments to ensure regulatory compliance
- Submitting necessary documentation for product clearances and approvals from regulatory bodies
- Contributing to the development and updating of regulatory strategy for new product development domestically and internationally
Additional tasks include:
- Developing and applying basic knowledge of regulatory frameworks, requirements, legislation, processes, and procedures
- Project management, writing, coordinating, and executing regulatory tasks
- Handling technical and scientific regulatory assignments of a broad nature
To succeed in this role, you are required to have:
- A Bachelor's or Master's degree in Regulatory Affairs, Engineering, or a related discipline
- A minimum of 3-5 years of experience in a similar position within an R&D environment
Possessing a Regulatory Affairs Certification (RAC) is also preferred. This role offers the opportunity to contribute to regulatory compliance and strategy in a dynamic environment with critical decision-making and collaboration with stakeholders.
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