Regulatory Affairs Specialist – Vascular

Abbott

Regulatory Affairs Specialist joining Abbott's vascular division to develop global regulatory strategies and support compliance for medical devices. Collaborating with cross-functional teams in a matrixed environment.

Posted 7/1/2026full-timeSanta Clara • California • 🇺🇸 United StatesJuniorMid-Level💰 $81,500 - $141,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing global regulatory strategies and preparing regulatory submissions for Vascular devices, with a strong focus on assessing regulatory impacts and supporting design control activities. Proven ability to communicate effectively across multiple levels in a fast-paced, team-oriented environment.

Highest-signal resume keywords

Regulatory Strategy DevelopmentRegulatory Submissions for Vascular DevicesRegulatory Impact AssessmentEngineering Change Order ReviewStrong Verbal and Written Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Impact EvaluationRegulatory Assessment DocumentationDesign Control SupportChange Management ActivitiesRegulatory Guidelines Analysis

Soft Skills

Team CollaborationEffective Communication

Industry Keywords

Regulated IndustryMedical ProductsNutritionalsProduct Lifecycle Management

About the role

Key responsibilities & impact

Evaluate regulatory impact and develop global regulatory strategies for product lifecycle management
Prepare and support regulatory submissions for Vascular devices
Assess proposed product, manufacturing, supplier, process, and labeling changes for regulatory impact
Develop and document regulatory assessments supporting design control and change management activities
Review and approve engineering change orders for documentation supporting new product development and sustaining activities
Act as a regulatory representative responsible for review and analysis of applicable regulatory guidelines

Requirements

What you’ll need

Bachelor’s degree (or equivalent)
2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals)
Ability to work within a team environment in a fast-paced matrixed setting
Strong verbal and written communication skills at multiple levels

Benefits

Comp & perks

Career development with an international company
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
Excellent retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit - an affordable path to getting a bachelor’s degree