Sr. Regulatory Affairs Specialist - Recall and Post-Market Compliance (Hybird/Remote)

Illumina • San Diego, CA

12d • Hybrid

About The Position

The Senior Regulatory Affairs Specialist is an instrumental member of Illumina’s Regulatory Affairs team, supporting on-market in vitro diagnostic (IVD) products in the United States and international markets. The role supports post-market regulatory compliance activities, including adverse event reporting, field actions, recalls, post-market surveillance, and regulatory assessments. It serves as a regulatory partner to cross-functional teams, providing guidance on regulatory requirements, risk evaluations, and reporting obligations.

The position conducts timely assessments of potential adverse events and field actions to determine regulatory reportability; supports MDR and recall decision-making; coordinates regulatory reporting; develops regulatory justifications and documentation; and helps ensure compliance with applicable global regulations. It also contributes to continuous improvement by developing and implementing regulatory procedures, work instructions, and best practices that strengthen post-market compliance and regulatory oversight.

Requirements

• Typically, at least 5 years of related experience with a bachelor’s degree; or 3 years with a master’s degree; or a PhD with no experience; or equivalent work experience.
• Strong understanding of FDA regulations.
• Ability to work independently with new, complex technologies and produce professional work products.
• Strong written and verbal communication skills.
• Familiarity and ability to work with office automation programs and corporate database tools.
• Strong work ethic and demonstrated ability to deliver assignments on time.

Nice To Haves

• Five or more years of Regulatory Affairs experience.
• Experience with an in vitro diagnostics device company; pharmaceutical, biologics, or medical device company experience may be an alternative.
• Knowledge of international regulatory requirements, including EU, Canada, Australia, Japan, and China.
• Team leadership skills.

Responsibilities

• 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 approvals, licenses, and authorizations for existing marketing authorizations.
• Prepare hardcopy and electronic information packages for submission to regulatory agencies.
• 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/or edit submission documents using regulatory templates, or create new templates.
• Assemble paper and/or electronic copies for submission.
• Monitor new and revised regulatory requirements and disseminate information as directed by management.
• Interact with regulatory agencies and third-party accrediting bodies.
• Prepare internal procedures for continuous process improvement.
• Provide regulatory guidance and/or training to external departments and partners.
• Assess potential adverse events and field actions for regulatory reportability and support MDR and recall decision-making.
• Coordinate regulatory reporting activities and develop regulatory justifications and documentation.

Benefits

• Variable cash program (bonus or commission); eligible roles may also receive equity.
• Access to genomics sequencing.
• Family planning benefits.
• Health, dental, and vision benefits.
• Retirement benefits.
• Paid time off.
• Employee Resource Groups that provide career development experiences, cultural awareness, and social responsibility engagement opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior