Principal Regulatory Affairs Specialist – Vascular

Abbott

. Develop and execute global regulatory strategies for product changes, manufacturing transfers, lifecycle management, new product development, and business objectives .

Posted 9/17/2026full-timeTemecula • California • United StatesLead💰 $86,700 - $173,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and executing regulatory strategies for medical devices, including preparation of FDA submissions and compliance with international regulations. Proven ability to lead cross-functional teams and manage regulatory activities throughout the product lifecycle.

Highest-signal resume keywords

Regulatory SubmissionsFDA 510(k) ExperienceEU MDR ComplianceRisk Management Under ISO 14971Regulatory Affairs Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentRegulatory Submissions for Medical DevicesKnowledge of 21 CFR 820ISO 13485 ComplianceTechnical Documentation PreparationClinical Data ReviewRisk-Based Regulatory AssessmentsChange Control ProcessesRegulatory Authority InspectionsRegulatory Documentation Review

Soft Skills

Critical ThinkingMultitaskingPrioritizationDeadline ManagementTeam Collaboration

Tools & Technologies

EDMSPLM SystemsEQMS Platforms

Certifications & Qualifications

RAC Certification

Industry Keywords

Medical Device IndustryClass II DevicesClass III DevicesCardiovascular DevicesEndovascular DevicesImplantable DevicesNotified Body InteractionsQuality Management System (QMS)Environmental Management System (EMS)International Regulatory Compliance

About the role

Key responsibilities & impact

Develop and execute global regulatory strategies for product changes, manufacturing transfers, lifecycle management, new product development, and business objectives
Independently prepare regulatory submissions and documentation for medical devices
Lead regulatory assessments for design, manufacturing, supplier, labeling, and process changes
Review and approve engineering change orders, protocols, reports, specifications, risk management documentation, validation documents, and project records
Support and maintain US and international product registrations, licenses, approvals, and technical documentation
Serve as regulatory lead on cross-functional project teams throughout product development and commercialization
Interpret and apply global regulatory requirements, standards, guidance documents, and industry best practices
Prepare and maintain FDA submissions, including 510(k)s, PMAs, PMA supplements, and other submissions
Support EU MDR activities, including Technical Documentation updates, change assessments, and notified body interactions
Collaborate with Regulatory Operations, Quality, Clinical, R&D, Manufacturing, Supply Chain, Marketing, and other functional groups
Analyze evolving regulatory requirements and recommend business-impact, compliance-risk, and implementation plans
Support regulatory authority and notified body inspections, audits, inquiries, and responses
Support company initiatives under QMS, EMS, and applicable regulatory requirements
Maintain compliance with FDA, international regulations, company policies, procedures, and quality requirements
Act as liaison between Abbott and regulatory agencies, including direct interfaces with FDA and Notified Bodies
May manage direct reports or mentor other regulatory affairs specialists
Perform other assigned duties

Requirements

What you’ll need

Bachelor’s Degree in a scientific discipline such as Chemistry, Life Sciences, or Biology, or equivalent vocational qualifications
Experience in regulatory submissions for pharmaceutical, in vitro diagnostic, and/or medical devices
Experience working within 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC)
6–8 years of experience in the medical device industry with Class II and/or Class III devices
Regulatory affairs experience supporting medical devices
Experience leading regulatory activities for cardiovascular, endovascular, peripheral vascular, implantable, catheter-based, or other complex medical device technologies
Strong working knowledge of QSR, ISO, and EN standards and regulatory requirements for the US, EU MDR, and other international geographies
Experience authoring and submitting Traditional, Special, or Abbreviated 510(k)s, PMAs, PMA supplements, IDEs, or other FDA submissions
Experience supporting EU MDR Technical Documentation, change notifications, clinical evaluation documentation, or notified body interactions
Knowledge of regulatory requirements and submission pathways in countries such as China, Canada, Australia, or Brazil
Experience participating in regulatory authority inspections, notified body audits, and responses to regulatory inquiries
Experience reviewing risk-based regulatory assessments and product risk management activities under ISO 14971
Experience reviewing clinical data
Experience with EDMS, PLM systems, eQMS platforms, and change control processes
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work effectively as a team member and individual contributor in a fast-paced, changing environment
Experience managing direct reports or serving as a dotted-line manager to regulatory affairs specialists
Ability to leverage, manage, and/or engage others to accomplish projects
Critical thinking, multitasking, prioritization, and deadline management
Ability to identify risk areas and escalate issues appropriately
Certification such as RAC is a plus, not required

Benefits

Comp & perks

Career development with an international company
Free medical coverage eligibility through the 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 toward a bachelor’s degree
Diverse career opportunities
Equal Opportunity Employer