Regulatory Affairs Specialist

. Manage product data attributes, certificates, and country‑specific compliance requirements within internal product data management, distribution‑control, and regulatory information management systems.

Posted 5/5/2026full-timeIrvine • California • 🇺🇸 United StatesMid-LevelSenior💰 $80,600 - $133,000 per yearWebsite

About the role

Key responsibilities & impact

Manage product data attributes, certificates, and country‑specific compliance requirements within internal product data management, distribution‑control, and regulatory information management systems.
Ensure data accuracy, consistency, and traceability to support global registrations, product releases, and lifecycle changes.
Partner with Regulatory colleagues to maintain regulatory and product data used for submissions to external regulatory databases, including GUDID and EUDAMED.
Perform routine data entry, validation, reconciliation, tracking, and reporting activities to support audits, inspections, and internal reviews.
Support the implementation and ongoing maintenance of new transitional distribution-control processes.
Monitor data dependencies and identify risks or issues that could impact product availability or regulatory compliance.
Partner closely with Master Data Management, Corporate RA, Advanced Patient Monitoring (APM) RA, In-Country RA, Supply Chain, Marketing, Labeling, Quality and IT/System Administration teams.

Requirements

What you’ll need

Strong attention to detail with excellent analytical, problem‑solving and organizational skills.
Proficiency in Excel and data manipulation or reporting tools.
Demonstrated ownership and accountability for assigned work.
Self‑motivated, proactive, and adaptable with a continuous learning mindset.
Ability to manage multiple priorities and stakeholders in a fast-paced, regulated environment.
Results‑driven, diligent, and able to work independently.
Strong written and verbal communication skills.
Bachelor’s degree in a scientific, engineering, or regulatory field (or equivalent experience).
Minimum of 3 years of experience in regulatory affairs, regulatory operations, data management, or a compliance‑driven environment.
Knowledge of EU MDR/MDD, FDA medical device regulations, and other international regulatory frameworks.
Familiarity with UDI requirements, CE marking, and country‑specific licensing processes.

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible work hours
Paid time off
Remote work options

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

data managementdata entrydata validationdata reconciliationdata trackingdata reportingExceldata manipulationregulatory submissionscompliance management

Soft Skills

attention to detailanalytical skillsproblem-solvingorganizational skillsownershipaccountabilityself-motivatedproactiveadaptabilitycommunication skills