Senior Specialist, Regulatory Affairs

ZOLL Medical Corporation

. Develop, implement, and lead regional regulatory strategies for new and sustaining ZOLL Resuscitation products and features .

Posted 11/6/2026full-timeMassachusetts • United StatesSenior💰 $101,600 - $152,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and implementing regulatory strategies for medical devices, with a strong focus on compliance, documentation, and stakeholder communication. Proven ability to lead cross-functional teams and maintain up-to-date knowledge of regulatory requirements.

Highest-signal resume keywords

Regulatory Affairs ExperienceElectro-Mechanical ProductsRegulatory Strategies DevelopmentRegulatory Affairs CertificationCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

IDE Submission510(k) SubmissionPMA SubmissionTechnical File PreparationDesign Dossier PreparationRisk AssessmentRegulatory ComplianceKPI TrackingContinuous ImprovementProject Deliverables

Soft Skills

Written CommunicationVerbal CommunicationTeam SupportStakeholder InterfaceAction Plan Creation

Certifications & Qualifications

Regulatory Affairs Certification

Industry Keywords

Medical Device IndustryElectro CardiologyDefibrillationRespiratory SpaceRegulatory Guidance

About the role

Key responsibilities & impact

Develop, implement, and lead regional regulatory strategies for new and sustaining ZOLL Resuscitation products and features
Implement regional regulatory strategies resulting in device approval
Keep project teams, management, and stakeholders informed of developments affecting regulatory success
Provide regional regulatory perspective during development, review, and approval of documentation supporting product development and commercialization
Ensure regulatory requirements are considered in programs and projects
Author and prepare IDE, 510(k), PMA, Technical File, Design Dossier, and other regional device application submissions
Work with management on risk assessment and regulatory compliance
Support cross-functional NPI project teams and provide regulatory guidance
Maintain current knowledge of regulations and guidance; collaborate with product teams on approvals and disseminate information
Lead, support, and coordinate internal and external resources to meet audit and compliance requirements
Promote continuous improvement, best practices, and innovation
Report on KPIs tracking continuous improvement progress and impact

Requirements

What you’ll need

Bachelor's Degree required
5+ years of regulatory affairs experience, preferably in the medical device industry
Proven experience with electro-mechanical products required
Experience building regulatory strategies to support successful regulatory affairs teams
Proven written and verbal communication skills to interface with a variety of stakeholders
Ability to create action plans and project deliverables
Ability to support team members in preparing suitable written responses to Regulatory Inquiries
Regulatory Affairs Certification preferred
Advanced Degree preferred
Experience in the electro cardiology or defibrillation/respiratory space preferred
Requires approximately 5%–10% travel

Benefits

Comp & perks

Annual bonus in accordance with the company's bonus plan
Hybrid / remote work arrangement
Comprehensive benefits plans
Reasonable accommodations in compliance with the Americans with Disabilities Act of 1990