Principal Regulatory Affairs Specialist – Vascular

Abbott

. Provide regulatory leadership for a portfolio of endovascular medical devices used to treat peripheral artery disease .

Posted 9/16/2026full-timeTemecula • California • United StatesLead💰 $86,700 - $173,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory leadership for endovascular medical devices, including the preparation of FDA submissions and compliance with global regulatory standards. Proven ability to manage multiple priorities while collaborating with cross-functional teams and mentoring regulatory affairs specialists.

Highest-signal resume keywords

Regulatory SubmissionsFDA SubmissionsEU MDR ComplianceRegulatory Affairs LeadershipRisk Management

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Hard Skills

Regulatory Strategy DevelopmentRegulatory Documentation PreparationRegulatory AssessmentsClinical Data ReviewRisk-Based Regulatory AssessmentsKnowledge of 21 CFR 820Knowledge of ISO 13485Knowledge of ISO 14971Experience with 510(k)sExperience with PMAs

Soft Skills

Attention to DetailAnalytical SkillsProblem-Solving SkillsOrganizational SkillsCommunication Skills

Tools & Technologies

Electronic Document Management SystemsProduct Lifecycle Management SystemsEQMS PlatformsChange Control Processes

Certifications & Qualifications

RAC Certification

Industry Keywords

Endovascular Medical DevicesPeripheral Artery DiseaseMedical Device IndustryClass II DevicesClass III DevicesNotified Body InteractionsGlobal Regulatory RequirementsCompliance RisksQuality Management SystemInternational Regulations

About the role

Key responsibilities & impact

Provide regulatory leadership for a portfolio of endovascular medical devices used to treat peripheral artery disease
Support global regulatory strategies throughout the product lifecycle
Develop and execute 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 actions regarding business impact, compliance risks, and implementation plans
Support regulatory authority and notified body inspections, audits, inquiries, and responses
Maintain compliance with QMS, EMS, FDA regulations, international regulations, company policies, procedures, and quality requirements
Act as liaison between Abbott and regulatory agencies, interfacing directly with FDA and Notified Bodies
Mentor regulatory affairs specialists and potentially manage direct reports
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 with regulatory submissions for pharmaceutical, in vitro diagnostic devices, 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 professional experience supporting medical devices
Experience leading regulatory activities for cardiovascular, endovascular, peripheral vascular, implantable, catheter-based, or other complex medical device technologies
Certification is a plus, such as RAC from the Regulatory Affairs Professionals Society
Ability to manage multiple competing priorities and programs with minimal oversight
Strong attention to detail
Strong written, verbal, presentation, organizational, analytical, and problem-solving skills
Working knowledge of QSR, ISO, and EN standards
Strong working knowledge of regulatory requirements for the US, EU (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 (2017/745) Technical Documentation, change notifications, clinical evaluation documentation, or notified body interactions
Knowledge of global regulatory requirements and submission pathways outside the United States and European Union, particularly 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 supporting product risk management activities in accordance with ISO 14971
Experience reviewing clinical data
Experience with electronic document management systems (EDMS), product lifecycle management (PLM) systems, eQMS platforms, and change control processes
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work effectively within a team and as an 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 timely deadline management
Ability to identify risk areas and escalate issues as appropriate

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 opportunities and support for career growth
Equal opportunity employer committed to employee diversity