Senior Regulatory Affairs Program Specialist

ZOLL Medical Corporation

Senior Regulatory Affairs Program Specialist responsible for regulatory compliance initiatives at ZOLL Medical Corporation. Leading collaboration with cross-functional teams and acting as a technical liaison with Regulatory Affairs.

Posted 7/28/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $105,000 - $125,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive regulatory experience in the Medical Device Industry, with a strong focus on compliance initiatives, technical liaison capabilities, and project management. Proficient in authoring standard operating procedures and engaging with regulatory authorities to ensure adherence to industry standards.

Highest-signal resume keywords

Regulatory ComplianceMedical Device ManufacturingRegulatory SubmissionsProject ManagementTechnical Liaison

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ExperienceMedical Device ComplianceTechnical WritingAnalytical AbilitiesProblem-Solving SkillsManufacturing KnowledgeChange Control UnderstandingEngineering ConceptsScientific TerminologyRegulatory Audits

Soft Skills

CollaborationCommunicationInitiativePressure ManagementTraining Skills

Certifications & Qualifications

Bachelor's Degree

Industry Keywords

Regulatory AuthoritiesFDAGlobal Regulatory SubmissionsMedical TerminologyStandard Operating Procedures

About the role

Key responsibilities & impact

Leading collaboration with cross-functional stakeholders to ensure regulatory compliance is met
Acting as the technical liaison between cross-functional departments and the Regulatory Affairs team
Evaluating and resolving regulatory and technical issues due to extensive knowledge of medical device manufacturing
Leading technical medical device compliance initiatives
Driving education of regulatory compliance to key business stakeholders
Reviewing global regulatory submissions for technical accuracy and regulatory compliance
Supporting technical inquiries for medical device regulatory submissions, registrations, licenses, clearances, approvals, and deficiencies
Collaborating with Engineering and R&D to develop the standards strategy for medical devices
Participating in regulatory audits/inspections as required
Authoring and maintaining standard operating procedures (SOPs) and training key personnel

Requirements

What you’ll need

Bachelor's Degree required
5+ years of regulatory experience in the Medical Device Industry required
Previous experience working with Regulatory Authorities relative to premarket and compliance activities required
Project management skills
Must be able to work under pressure to meet regulatory reporting time frames and company requirements
Must be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolution
Experience interacting with FDA and/or other regulatory agencies
Proven analytical abilities, able to apply problem-solving skills for problems of moderate to diverse scope
Understanding of manufacturing and change control, and an awareness of regulatory trends
Understanding of engineering concepts and scientific terminology
Documented evidence of writing skills
Strong understanding of medical terminology

Benefits

Comp & perks

Comprehensive benefits plans available at www.zollbenefits.com
Annual bonus eligibility in accordance with the company's bonus plan