Senior Regulatory Affairs Specialist – Vascular

Abbott

. Provide support for the regulatory department to ensure efficient and compliant business processes and environment .

Posted 9/17/2026full-timeTemecula • California • United StatesSenior💰 $78,000 - $156,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance, product registration, and submission processes within highly regulated industries. Proficient in analyzing regulatory requirements and collaborating across business functions to ensure efficient product lifecycle management.

Highest-signal resume keywords

Regulatory Submission PreparationExperience with US 510(k) and PMARegulatory Compliance Risk-Benefit AnalysisInteraction with Regulatory AuthoritiesBachelor's Degree in Science/Technical Discipline

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentData Analysis for Product RegistrationQuality Documentation AssessmentRegulatory History InvestigationSubmission Filing StrategiesLabeling Development ComplianceChange Management AssessmentClinical Data ReviewMonitoring Regulatory ChangesCumulative Product Change Analysis

Soft Skills

Effective Verbal and Written CommunicationStrong Organizational SkillsAttention to DetailCritical ThinkingMultitasking

Certifications & Qualifications

RAC Certification

Industry Keywords

Regulated Industry ExperienceMedical Device IndustryUS FDA InteractionEU Notified Body ExperienceInternational Market Regulations

About the role

Key responsibilities & impact

Provide support for the regulatory department to ensure efficient and compliant business processes and environment
Partner across business functions to support continued on-market access of products and new product development
Identify and obtain data needed for product registration and ensure data are effectively presented
Prepare and submit documentation for worldwide product registration or oversee its preparation
Provide regulatory input to product lifecycle planning
Assist in developing regional regulatory strategy and update strategy based on regulatory changes
Investigate regulatory history and disease, therapeutic, or diagnostic context to assess approval implications
Determine and communicate submission and approval requirements
Participate in regulatory compliance risk-benefit analysis
Assess quality, preclinical, and clinical documentation for submission filing
Compile, prepare, review, and submit regulatory submissions
Monitor changing regulations, submission strategies, applications under review, and applicable regulatory reports
Evaluate preclinical, clinical, and manufacturing changes for regulatory filing strategies
Interact and negotiate with regulatory authorities during development and review
Maintain annual licenses, registrations, and listings
Support compliance with post-marketing approval requirements
Assess external communications for regulatory compliance
Assist with labeling development and compliance review
Support change management by assessing regulatory impact and submission requirements
Analyze cumulative product changes to current submissions
Provide regulatory input for non-conforming products, field actions, and CAPA
Assist with internal and external site audits

Requirements

What you’ll need

Bachelor's Degree in a related field OR an equivalent combination of education and work experience
3–4 years of experience in a regulated industry
2–3 years of experience in regulatory preferred; quality assurance, research and development/support, scientific affairs, operations, or related experience may be considered
Effective verbal and written communication; ability to prepare and negotiate internally and externally with regulatory agencies
Strong organizational, follow-up, and attention-to-detail skills
Ability to organize and track complex information
Good and ethical judgment within policy and regulations
In-depth knowledge of business functions and cross-group dependencies/relationships
Ability to follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issues with supervision
Preferred: bachelor’s degree in science/technical discipline
Preferred: experience with US 510(k), PMA, and EU Technical Documentation and Change Notification submissions
Preferred: experience interacting with US FDA and EU Notified Body
Preferred: experience with highly regulated international markets, including China, Canada, Australia, and Brazil
Preferred: experience reviewing clinical data
Preferred: ability to work in a highly matrixed and geographically diverse business environment
Preferred: ability to work within a team and as an individual contributor in a fast-paced, changing environment
Preferred: ability to leverage, manage, and/or engage others to accomplish projects
Preferred: critical thinking, multitasking, prioritization, and timely deadline management
Preferred: experience working in the medical device industry
Certification such as RAC is a plus

Benefits

Comp & perks

Career development with an international company
Free medical coverage in the Health Investment Plan (HIP) PPO medical plan for qualifying employees
Retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit toward a bachelor’s degree
Equal Opportunity Employer committed to employee diversity