Medical Device, Quality/Risk Management, Worldwide Regulatory Affairs
4 Year Degree
Primary Job Functions:
Support and manage regulatory advertising and promotional activities. This will include functioning as the primary, dedicated Regulatory Affairs (RA) reviewer of advertising and promotional materials through Illumina’s cross-functional Content Approval Process (CAP).
Support and manage regulatory compliance activities by conduct reportability assessments for on-market diagnostic products worldwide. Document health hazard assessments in coordination with Medical Affairs. Communicate with regulatory agencies for U.S. and International regulatory compliance issues related to adverse event and field action reporting. Assist with development and/or review of customer communications related to product quality. Provide strategic and operational guidance on regulatory compliance processes including development and implementation of related procedures. Work with Quality Assurance to implement effective complaint handling and nonconforming product processes and training. Participate as a subject matter expert (SME) during inspections and audits.
Regulatory Affairs (RA) team lead on the review of advertising and promotional materials.
Monitor new and revised regulatory requirements and developments relating to the advertising and promotion of medical devices.
Mentor regulatory staff and other relevant stakeholders within Illumina on best practices regarding the development of advertising claims and promotional practices
RA team lead on all customer complaint and nonconforming product regulatory compliance assessments for on-market products.
Work closely with Quality Assurance and investigation teams to assess, respond, and track potential adverse events and/or field actions.
Ensure clear and compliant documentation for investigations related to customer complaints or nonconforming product in the field.
Provide compliance process guidance and/or training to internal departments and Illumina front line support.
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.
Ensure compliance with regulatory compliance regulations (e.g., US FDA QSRs, Europe IVDD/IVDR/MEDDEV 2 12-1, Health Canada regulations, MDSAP requirements, ISO 13485, etc.).
Assist with development and/or review of customer communications related to product quality and/or field actions.
Create and submit all documentation related to device recall reporting within the U.S. and worldwide.
Write and/or edit process documents using RA templates or create new templates in support of continuous RA process improvement.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
7+ years’ experience in Regulatory Affairs at an in vitro diagnostics device company (preferred), medical device, pharmaceutical, or biologics manufacturing company
Strong knowledge of U.S. FDA regulations governing the advertising and promotion of medical devices.
Experience working with or understanding of advertising and promotion regulations in other global markets (e.g. the EU, Australia, Canada, Japan)
Strong knowledge of U.S. FDA regulation pertaining to medical device/IVD adverse event and field action assessment, health hazard evaluation, product risk safety analyses, MDR/AE/recall reporting, and process requirements.
Strong knowledge of Vigilance reporting to International regulatory agencies.
Knowledge of IVD/Medical Device labeling requirements and FDA 21 CFR 820.
Demonstrated ability to work independently with new, complex technologies, office automation programs and corporate database tools to produce professional work products.
Strong and effective communicator across various levels, and with both internal and external stakeholders.
Team leadership skills and strong written and verbal communication skills.
Strong work ethic and demonstrated ability to deliver assignments on time.
Internal Number: 11630-JOB
About Illumina, Inc.
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments.
Illumina has experienced phenomenal growth from $10 million in revenues in 2002 to approximately $2.2 billion in 2015. Forbes named Illumina #1 on the 2009 list of 25 Fastest-Growing Technology Companies in the United States, the second time over a three-year period that Forbes ranked Illumina #1 on its list of rapidly growing technology companies. Illumina was also named #1 smartest company in the world as part of MIT’s 2014 Technology Review. As of February 2016, the company had a $21 billion market capitalization.