Senior Regulatory Affairs Specialist – Vascular

Abbott

. Provide regulatory support 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 support, including worldwide product registration, compliance, and submission preparation. Possesses strong organizational skills and the ability to navigate complex regulatory environments while effectively communicating with regulatory authorities.

Highest-signal resume keywords

Regulatory Affairs ExperienceUS 510(k) SubmissionsEU Technical DocumentationRegulatory Risk-Benefit AnalysisRegulatory Affairs Certification (RAC)

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission PreparationClinical Data ReviewRegulatory Strategy DevelopmentRegulatory Compliance AssessmentData Presentation for RegistrationQuality Documentation AssessmentChange Management SupportRegulatory History InvestigationSubmission Requirement CommunicationPost-Marketing Approval Compliance

Soft Skills

Effective CommunicationOrganizational SkillsAttention to DetailCritical ThinkingNegotiation Skills

Certifications & Qualifications

Regulatory Affairs Certification (RAC)

Industry Keywords

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

About the role

Key responsibilities & impact

Provide regulatory support to ensure efficient and compliant business processes and environment
Partner across business functions to support continued on-market access and new product development
Identify, obtain, and effectively present data needed for worldwide product registration
Prepare and submit documentation for worldwide registration or oversee its preparation
Provide regulatory input to product lifecycle planning
Develop and update regional regulatory strategies based on regulatory changes
Investigate regulatory history and therapeutic/diagnostic context to assess approval implications
Determine and communicate submission and approval requirements
Participate in regulatory risk-benefit analysis
Assess quality, preclinical, and clinical documentation for submission filing
Compile, prepare, review, and submit regulatory submissions
Monitor regulatory changes, applications under review, and required reports
Evaluate preclinical, clinical, and manufacturing changes for filing strategies
Interact and negotiate with regulatory authorities during development and review
Maintain annual licenses, registrations, and listings
Support post-marketing approval compliance
Assess external communications and labeling for regulatory compliance
Support change management and analyze cumulative product changes
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, preparation, and negotiation with internal and external regulatory agencies
Strong organizational and follow-up skills and attention to detail
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 a science/technical discipline
Experience with US 510(k), PMA, and EU Technical Documentation/Change Notification submissions
Experience interacting with US FDA and EU Notified Body
Experience with highly regulated international markets, including China, Canada, Australia, or Brazil
Experience reviewing clinical data
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to leverage, manage, and/or engage others to accomplish projects
Critical thinking and ability to multitask, prioritize, and meet deadlines
Experience in the medical device industry preferred
Regulatory affairs 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
Excellent retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit toward a bachelor’s degree
Health and wellness benefits
Equal Opportunity Employer committed to employee diversity