Sr. Regulatory Affairs Specialist-CT/AMI

Job Title
Sr. Regulatory Affairs 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.

Your role:

• 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. Additionally, responsible for reviewing Marketing Communication materials for promotional purposes.
• Responsible for: Key program/project deliverables by developing Regulatory project plans, product registrations/approvals, the coordination and preparation of document packages for regulatory submissions from all areas of company.
• Participates in program/project meetings to provide guidance on the worldwide regulatory requirements for medical devices and external government product audits by China, Korea, Japan, and other inspection agencies as needed.
• Compiles all materials required in submissions, license renewal, initial product reports and annual product reports. Reviews and recommends changes for labeling, and clinical protocols to maintain regulatory compliance. Keeps abreast of current regulatory procedures and changes. Participates in direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.
• Regulatory Affairs representative for the CT/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. Defect and complaint reviews for program teams, provides guidance to the team on risk assessment and required corrective actions to meet regulatory requirements.
• Responsible for the coordination and preparation of document packages 510(k) Pre-market Notifications, Technical File and Design Dossiers for CE marking, initial product reports and annual Reports for regulatory submissions.
• Drives improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System. Reviews and recommends changes for design process and manufacturing procedures to maintain quality and regulatory compliance.
• Key role in external audits related to product submission such as FDA, 3rd party external regulatory agencies like SFDA, KFDA, JPAL, etc. and notified body audits. Implements internal or external quality system audits.
• Reporting to the Director of Regulatory Affairs, the Senior RA Specialist will collaborate with global team members, cross-functional teams, and stakeholders.
• This Hybrid based role may require travel up to 10%, (possibly International).

• You've acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K's, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
• You have detailed knowledge of ISO 13485, medical device regulations (21CFR), Software (ISO 62304/82304) FDA law, CE marking, QSR requirements and experience supporting international registrations.
• You have a minimum of a Bachelor's Degree in Regulatory Affairs, technical or science related field (Required). Master's degree desired. RAPs RAC strongly preferred.
• You have strong written, oral, and interpersonal skills to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

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