Senior Regulatory Affairs Specialist – Recall and Post-Market Compliance

Job not on LinkedIn

🔥 1 minute ago

🏄 California, Massachusetts, +3 more states – Remote

🏄 California – Remote 🍂 Massachusetts – Remote ❄️ Minnesota – Remote 🤠 Texas – Remote 🧀 Wisconsin – Remote

💵 $90k - $135k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Illumina

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1998

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $750M Post-IPO Debt on 2023-01

Healthcare • Consulting • Manufacturing

Illumina is a leading company in the genomics field, providing innovative technologies for the analysis of genetic variation and function. They offer a wide range of products and services, including sequencing platforms, microarray technology, library preparation kits, bioinformatics software, and comprehensive genomic solutions. Illumina's next-generation sequencing platforms are used for various research and clinical applications, such as cancer research, reproductive health, and genetic disease detection. The company is dedicated to improving human health by enabling researchers and clinicians to accelerate their genomic discoveries and applications, ultimately impacting precision medicine and life sciences globally.

📋 Description

• Represent the Regulatory Affairs function on assigned cross-functional project teams • Interpret and apply regulations by creating regulatory strategies for domestic and international markets • Develop and execute regulatory plans for complex projects, including new products and maintenance of existing marketing authorizations • Prepare hardcopy and electronic information packages for regulatory agency submissions • Provide recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance • Review validation, clinical, and stability protocols and reports for regulatory submission soundness • Assess manufacturing processes and labeling through change control for regulatory reporting impact and compliance • Define, monitor, and receive submission deliverables • Write and edit submission documents using regulatory templates or create new templates • Assemble paper and electronic copies for submission • Monitor new and revised regulatory requirements and disseminate information • Interact with regulatory agencies and third-party accrediting bodies • Prepare internal procedures for continuous process improvement • Provide regulatory guidance and training to external departments and partners • Support adverse event reporting, field actions, recalls, post-market surveillance, and regulatory assessments for on-market IVD products

🎯 Requirements

• Minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience • 5+ years of experience in Regulatory Affairs preferred • Experience with an in vitro diagnostics device company preferred; pharmaceutical, biologics, or medical device company experience accepted as an alternative • Strong understanding of FDA regulations required • Knowledge of EU, Canada, Australia, Japan, and China regulatory requirements preferred • Ability to work independently with new, complex technologies and produce professional work products • Strong written and verbal communication skills • Team leadership skills preferred • Familiarity with office automation programs and corporate database tools • Strong work ethic and ability to deliver assignments on time • Must be eligible to work without visa sponsorship

🏖️ Benefits

• Variable cash program (bonus or commission) • Equity for eligible roles • Access to genomics sequencing • Family planning benefits • Health, dental, and vision benefits • Retirement benefits • Paid time off • Employee Resource Groups offering career development experiences, cultural awareness, and social responsibility opportunities