Regulatory Affairs Specialist

Grifols

Regulatory Affairs Specialist responsible for compliance and regulatory documentation in healthcare. Working at Grifols' Vista, CA facility for plasma-derived medicine.

Posted 5/8/2026full-timeVista • California • 🇺🇸 United StatesMid-LevelSenior💰 $80,546 - $120,819 per yearWebsite

About the role

Key responsibilities & impact

Administrate Error and Accident (Deviation) procedure and process; perform all required data entry, paperwork, file maintenance, written and verbal communications, and follow up within the required time constraints
Oversight of data entries in the GBS DDL
Assist Regulatory Management with product deviation reporting to the FDA
Updates and distributes annual facility FDA reports
Assists with regulatory submissions, annual reports, and regulatory responses
Assures that appropriate maintenance of registrations occurs including renewals, site registrations, supplements for change
assist with compiling and submitting reportable events
support regulatory agency audits
assist with the review of product labels and commercial materials to prevent findings of non-compliance
Receive and review monthly viral marker data information, maintain associated files; perform data entry and follow up with centers as needed
Create, review and mail Doctor, Manager, and Physician Substitute Approval Letters. Maintain associated files
Help management ensure compliance with Food and Drug Administration (FDA) regulations and all policies, guidelines, and standard operating procedures (SOPs) related to deviation management
Maintain updated CFR access for donor center and manufacturing operations
Coordinates Deviation management process to ensure timely reporting and closure for GBS whole blood, source plasma and manufacturing operations
Coordinate the recall procedure and process, contact centers for recall documentation. Coordinate customer communications with Customer Support for final disposition of product
Receive and review data for Look Back Reports and Post Donation Information Reports; generate and prepare associated customer notifications
Performs review of Deviation Reports and associated documentation to ensure completeness, including documented evidence of impact assessments as a part of risk management and completion of all CAPA actions required by the report have occurred
Coordinates training on deviation management procedures
Maintains a master library/database of all Deviation documents
Maintains secured filing and storage system for archived hard copies of Deviation Reports
Prepares/proofs document content and formatting for all Deviation Reports
Coordinates with document authors, owners, and reviewers to resolve content and formatting
Maintains a master library / database of all SOPs, forms, job aids, and training documents
Maintains secured filing and storage system for archived hard copy / controlled documentation
Additional duties as assigned by management

Requirements

What you’ll need

5-10% Travel
Intermediate to advanced computer skill in Microsoft Word, Outlook, Excel
Cell Therapy or Cell Culture experience highly preferred
Advanced understanding of Good Manufacturing Practices (GMPs), FDA & EU Regulatory requirements
Excellent interpersonal and communication skill
Must possess customer service skills and display attention to detail
Experience with Deviation Management system a plus
Must be flexible and able to multi-task in a fast-paced environment, and team player
Must be able to proof work and identify non-standard format or wording and errors within documents
Associates degree or equivalent

Benefits

Comp & perks

Medical
PTO
Up to 5% 401K match
Tuition reimbursement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

data entryregulatory submissionsdeviation managementrisk managementdocument proofingreport generationfile maintenancecustomer notificationscomplianceGood Manufacturing Practices (GMPs)

Soft Skills

interpersonal skillscommunication skillscustomer service skillsattention to detailflexibilitymulti-taskingteam player

Certifications

Associates degree