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Sr. Regulatory Affairs Specialist / AMI
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- Job Title Sr. Regulatory Specialist-CT/AMI Job Description The Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps—understanding competitive claim landscape, legislative initiatives, and marketing strategy.
- The Senior RA Specialist provides the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as CE Marking per MDD, EU MDR (updating Technical Files), 510(k) Worldwide product registrations, clinical evaluations.
- Post market surveillance.
- Regulatory Affairs representative for theCT/AMI Systems and assists with regulatory issues related to such items as labeling and marketing ideas, claim development and prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of regulatory applications for a program.
- Reporting to the Director of Regulatory Affairs, the Senior RA Specialist will collaborate with global team members, cross-functional teams, and stakeholders.
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