Senior Regulatory Affairs Specialist – Recall and Post-Market Compliance

Illumina

. Represent the Regulatory Affairs function on assigned cross-functional project teams .

Posted 10/12/2026full-timeRemote • United StatesSenior💰 $90,000 - $135,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs with a strong understanding of FDA regulations and international regulatory requirements. Capable of developing and executing regulatory strategies, preparing submission documents, and providing regulatory guidance for in vitro diagnostics and related products.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA Regulations KnowledgeIn Vitro Diagnostics ExpertiseRegulatory Submission PreparationTeam Leadership Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentRegulatory Plan ExecutionSubmission Document WritingRegulatory Compliance AssessmentChange Control AssessmentValidation Protocol ReviewClinical Study Plan RecommendationsAdverse Event ReportingPost-Market SurveillanceContinuous Process Improvement

Soft Skills

Strong Written CommunicationStrong Verbal CommunicationAbility to Work IndependentlyStrong Work EthicTeam Leadership

Tools & Technologies

Office Automation ProgramsCorporate Database Tools

Industry Keywords

In Vitro DiagnosticsPharmaceuticalsBiologicsMedical DevicesRegulatory Agency InteractionInternational Regulatory RequirementsFDA ComplianceEU Regulatory RequirementsCanada Regulatory RequirementsJapan Regulatory Requirements

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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