Senior Regulatory Affairs Specialist

Insulet Corporation

. Lead domestic and international regulatory registrations and submissions activities .

Posted 9/22/2026full-timeUnited StatesSenior💰 $91,700 - $137,525 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs for medical devices, including pre-market and post-market submissions, compliance with domestic and international regulations, and effective collaboration with cross-functional teams. Proficient in preparing regulatory documentation and ensuring adherence to guidelines such as 21 CFR 820 and ISO 13485.

Highest-signal resume keywords

Regulatory Affairs Experience510(k) SubmissionsRAC CertificationKnowledge of 21 CFR 820ISO 13485 Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsRegulatory Guidelines KnowledgeECO ReviewSpecification Document ReviewChange Assessment EvaluationPre-Market ApprovalPost-Market ApprovalClinical Study SupportDocumentation PreparationRegulatory Impact Review

Soft Skills

Effective CommunicationOrganizational SkillsMulti-Priority Management

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft VisioMicrosoft Project

Certifications & Qualifications

RAC Certification

Industry Keywords

Medical Device RegulationsFDA SubmissionsCE MarkingCMDRMDD

About the role

Key responsibilities & impact

Lead domestic and international regulatory registrations and submissions activities
Support regulatory approval initiatives for medical devices in domestic and international markets
Provide regulatory affairs support for product development, manufacturing, and clinical studies, including pre-market, post-market, and physician-initiated studies
Support ongoing compliance and corporate initiatives
Partner with Marketing and Development teams on marketed products, labeling, promotional materials, product changes, and documentation requiring government approval
Compile and submit documentation supporting marketing initiatives
Review marketing, sales, packaging, and labeling materials for regulatory impact
Represent Regulatory Affairs on project teams and in meetings involving labeling and promotion decisions
Assist with pre-market and post-market filings, including 510(k), IDE, PMA, CE Marking, Canadian, EU, and ROW registrations
Prepare submissions and reports for FDA and other international agencies
Plan, create, organize, and interpret regulatory documents for submission
Review and approve specifications, procedures, schedules, test protocols, reports, and validations
Evaluate and present change assessments to support timely compliance
Review, evaluate, and approve Engineering Change Orders, especially significant changes and revisions
Perform other duties as required

Requirements

What you’ll need

B.S. / B.A. or equivalent combination of education and experience
5+ years of regulatory medical device industry experience
RAC Certification preferred
Knowledge of regulatory guidelines and requirements (domestic and international)
Experience with reviewing ECOs, Requirements, and Specification Documents
Understanding of 21 CFR 820, CMDR, ISO 13485, MDD
Effective verbal and written communication skills
Ability to communicate at multiple levels of an organization
PC skills, including Word, Excel, PowerPoint, Visio, and Project
Ability to organize and manage multiple priorities
Ability to generate and maintain accurate records
Must work onsite from an Insulet office as part of the hybrid arrangement

Benefits

Comp & perks

Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
Additional employee wellness programs
Incentive compensation eligibility