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2 weeks ago
This critical role plays a pivotal part in supporting the product lifecycle through strategic assessments and evaluations. It involves determining the regulatory impact of post-launch changes on existing clearance and ensuring compliance by conducting thorough assessments, submitting necessary documentation, and collaborating with regulatory bodies.
Key Responsibilities:- Conducting regulatory impact assessments for post-launch changes
- Ensuring regulatory compliance by submitting necessary documentation
- Contributing to the development and updating of regulatory strategy for new product development both domestically and internationally
In this capacity, you will work independently with minimal supervision, collaborating with senior staff as needed and keeping your supervisor informed of your progress. Your tasks will involve developing and applying advanced knowledge of regulatory frameworks, requirements, legislation, processes, and procedures.
Requirements:- Bachelor's or Master's degree in Regulatory Affairs, Engineering, or a related discipline
- Minimum 3-5 years of experience in a similar position within an R&D environment
- Experience in post-market activities and change management advantageous
- Regulatory Affairs Certification (RAC) preferred
This position offers the opportunity to contribute to regulatory compliance and strategy in a dynamic environment, involving critical decision-making, collaboration with stakeholders, and ensuring adherence to regulatory requirements throughout the product lifecycle.
Benefits:This role provides the chance to apply your expertise in a rapidly evolving field, driving innovation and growth while upholding the highest standards of regulatory excellence.
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