Sr. Regulatory Affairs Specialist - Recall and Post-Market Compliance (Hybird/Remote)
Illumina
Summary
The Senior Regulatory Affairs Specialist will be an instrumental member of the Regulatory Affairs team supporting on-market in vitro diagnostic (IVD) products in the United States and international markets. This role is responsible for supporting post-market regulatory compliance activities, including adverse event reporting, field actions, recalls, post-market surveillance, and regulatory assessments. The individual will serve as a key regulatory partner to cross-functional teams, providing guidance on regulatory requirements, risk evaluations, and reporting obligations.
Job description
Key responsibilities include conducting timely assessments of potential adverse events and field actions to determine regulatory reportability, supporting MDR and recall decision-making, coordinating regulatory reporting activities, developing regulatory justifications and documentation, and ensuring compliance with applicable global regulations. The role will also contribute to continuous improvement initiatives through the development and implementation of regulatory procedures, work instructions, and best practices that strengthen post-market compliance and regulatory oversight.
Responsibilities
- Represents the RA function on assigned cross-functional project teams
- Interprets and applies regulations by creating regulatory strategies for domestic and international markets
- Develops and executes regulatory plans for complex projects including new products and maintenance of approvals/licenses/authorizations for existing marketing authorizations
- Prepares hardcopy and electronic information packages for submission to regulatory agencies
- Provides recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance
- Reviews validation, clinical and stability protocols and reports for regulatory submission soundness
- Assesses manufacturing process and labeling through change control for regulatory reporting impact and compliance to regulations
- Defines, monitors and receives deliverables for submissions
- Writes and/or edits submission documents using regulatory templates, or creates new templates
- Assembles paper and/or electronic copies for submission
- Monitors new and revised regulatory requirements; disseminates information as directed by management
- Interacts with regulatory agencies and third party accrediting bodies
- Prepares internal procedures for continuous process improvement
- Provides regulatory guidance and/or training to external departments and partners
Experience/Education
Typically requires a 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.
Preferred Experiential Background
- 5+ years experience in Regulatory Affairs
- Experience with an in vitro diagnostics device company preferred; pharmaceutical, biologics or medical device companies as alternative
- Strong understanding of FDA regulations required; other international requirements - EU, Canada, Australia, Japan and China - preferred
- Demonstrated ability to work independently with new, complex technologies and produce professional work products
- Strong written and verbal communication skills
- Team leadership skills preferred
- Familiarity and ability to work with office automation programs and corporate database tools
- Strong work ethic and demonstrated ability to deliver assignments on time
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 experience in Regulatory Affairs
- Strong understanding of FDA regulations required
- Experience with an in vitro diagnostics device company preferred; pharmaceutical, biologics or medical device companies as alternative
- Demonstrated ability to work independently with new, complex technologies and produce professional work products
- Strong written and verbal communication skills
- Team leadership skills preferred
- Familiarity and ability to work with office automation programs and corporate database tools
- Strong work ethic and demonstrated ability to deliver assignments on time
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Retirement benefits
- Paid time off
- Variable cash programs
- Equity
- Genomics sequencing access
- Family planning
Company overview
Illumina is a global leader in genomics technology, founded in 1998 and headquartered in San Diego, California. As a pioneering biotechnology company, Illumina specializes in developing, manufacturing, and marketing integrated systems for genetic analysis, with a primary focus on DNA sequencing and array-based technologies. The company's mission is to improve human health by unlocking the power of the genome, serving customers across research, clinical, and applied markets worldwide. Illumina's innovative platforms, including the NovaSeq, HiSeq, MiSeq, and NextSeq series, have revolutionized genomic research and clinical applications, enabling breakthroughs in personalized medicine, disease research, and drug development. With over 9,000 employees across 27 countries, Illumina has established itself as the dominant force in next-generation sequencing, processing more than 90% of all DNA sequencing data globally. The company's technologies support diverse applications from cancer research and rare disease diagnosis to agricultural genomics and infectious disease surveillance, making genomic insights accessible to researchers and clinicians worldwide.