Quality/Risk Management, Submission & Registration, US Regulatory Affairs
4 Year Degree
Work at a Regulatory Affairs (RA) Manager capacity as a member of the RA team to support IVD product development teams, U.S. and international submissions and technical documentation, advertising and promotion review, change management, and regulatory compliance. Interact with various corporate functions and provide regulatory guidance as needed. Write and implement regulatory procedures for continuous improvement. Ensure timely and effective assessments of new regulatory information to determine impact on Illumina products and processes.
Job Functions: Work at a Regulatory Affairs (RA) Manager capacity as a member of the RA team to support IVD product development teams, U.S. and international submissions and technical documentation, advertising and promotion review, change management, and regulatory compliance. Interact with various corporate functions and provide regulatory guidance as needed. Write and implement regulatory procedures for continuous improvement. Ensure timely and effective assessments of new regulatory information to determine impact on Illumina products and processes.
Participate on product development core teams as the regulatory representative.
Interpret and apply regulations by creating regulatory product strategies for domestic and international markets.
Author, edit, and review regulatory submissions using existing templates or newly created templates.
Review verification and validation documentation, including clinical studies, labeling and manufacturing information for compliance and regulatory submission soundness.
Define, monitor and track deliverables for U.S. and International submissions.
Prepare hardcopy and electronic information packages for submission to regulatory agencies.
Review design and manufacturing changes for regulatory compliance and reporting impact.
Assist on the review of advertising and promotional materials.
Ensure clear and compliant documentation for investigations related to customer complaints or nonconforming product in the field.
Ensure compliance with applicable regulations (e.g., US FDA QSRs, Europe IVDD/IVDR/MEDDEV 2 12-1, Health Canada regulations, MDSAP requirements, ISO 13485, etc.).
Interact with regulatory agencies and third-party accrediting bodies to ensure regulatory compliance.
Participate as a subject matter expert (SME) during FDA, Notified Body, and other regulatory related inspections and audits as it relates to regulatory reporting compliance.
8+ years of experience in Regulatory Affairs at an in vitro diagnostics device company (preferred), medical device, pharmaceutical, or biologics manufacturing company.
Proven experience in authoring submissions or technical documentation such as 510(k), PMA, design dossiers, STED, etc.
Proven experience interacting with domestic and international regulatory agencies dealing with matters of regulatory compliance.
Knowledge of related IVD/medical device regulations.
Strong and effective communicator across various levels and with both internal and external stakeholders.
Strong written and verbal communication skills and project management skills.
Demonstrated ability to work independently with new, complex technologies, office automation programs and corporate database tools to produce professional work products.
Strong work ethic and demonstrated ability to deliver assignments on time.
Must be productive, demonstrate the ability to deal with timeline stress, be able to cope with multiple tasks, and be able to prioritize tasks with the supervisor input.
Internal Number: 15091-JOB
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