Job Description

Regulatory Affairs Specialist - Labeling We’re actively seeking a qualified candidate for the Regulatory Affairs Specialist – Labeling position, responsible for ensuring compliance with EU, US (21 CFR), and ISO labeling standards across all product life‑cycle stages. Responsibilities Accountable for regulatory labeling deliverables for various project types, including submissions, new product development, sustaining updates, launches, and manufacturing transfer. Manage and support assessment and template creation for new and changing labeling requirements. Prepare technical product documentation such as plans, reports, and engineering change orders. Maintain artwork content for all labeling types—product labels, patient labeling, electronic labeling, cartons, and instructions for use—in compliance with applicable regulations, standards, company policies, and internal labeling requirements. Estimate labeling projects’ level of effort, resource requirements, and work with stakeholders to define scope and tasks. Collaborate with cross‑functional teams (R&D, marketing, manufacturing, operations, regulatory, legal, quality, clinical, medical safety) to facilitate labeling artwork project completion. Track labeling project schedules, identify risks/issues, determine resolution, and communicate project status or escalations in departmental and project team meetings. Keep abreast of regulatory procedures and changes; may direct interaction with regulatory agencies on defined matters. Manage labeling, UDI, and barcode grading processes and systems as related to product labeling; perform other duties as assigned. Qualifications Required: MS in Science, Engineering, or Regulatory Affairs. Years of Experience: 5‑9 years in regulatory labeling or related field. Demonstrated experience in coordinating and preparing document packages for regulatory submissions, internal audits, and inspections. Ability to lead or compile all materials required in submissions, license renewal, and annual registrations. Strong knowledge of EU MDR, ISO15223, ISO20417, 21 CFR 801, and global labeling standards. Project management and change management skills. Excellent communication skills and ability to influence internal stakeholders. Differentiating Factors Autonomy: Works independently with general supervision on moderately complex projects. Organizational Impact: Sets objectives for own job area to meet project objectives and contributes to project milestones. Innovation: Adjusts or recommends enhancements in systems and processes to improve job effectiveness. Communication: Communicates primarily with internal contacts; external interactions are less complex. Leadership: May provide guidance to entry‑level professionals. Employment Details Seniority Level: Associate Employment Type: Contract Job Function: Legal Industry: Medical Equipment Manufacturing Location: Irvine, CA Salary: $69,510.00–$126,382.00 #J-18808-Ljbffr IntePros

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