Senior Regulatory Affairs Specialist

Insulet Corporation

. Lead activities supporting domestic and international regulatory registrations and submissions .

Posted 9/15/2026full-timeActon • California • United StatesSenior💰 $91,700 - $137,525 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory submissions and compliance for medical devices, including knowledge of 21 CFR 820, CMDR, and ISO 13485. Proven ability to collaborate with cross-functional teams and manage multiple priorities effectively.

Highest-signal resume keywords

Regulatory SubmissionsMedical Device Industry ExperienceRAC CertificationKnowledge of Regulatory GuidelinesEffective Communication Skills

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory Approval510(k) SubmissionsIDE SubmissionsPMA SubmissionsCE MarkingChange AssessmentSpecification ReviewQuality Fitness EvaluationDocumentation CompilationRegulatory Impact Review

Soft Skills

Organizational SkillsVerbal CommunicationWritten CommunicationMulti-level CommunicationPriority Management

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft VisioMicrosoft Project

Certifications & Qualifications

RAC Certification

Industry Keywords

Regulatory AffairsMedical DevicesPre-market ApprovalPost-market ComplianceClinical StudiesPromotional MaterialsLabeling ChangesVendor DocumentationQuality Management SystemsEngineering Change Orders

About the role

Key responsibilities & impact

Lead activities supporting domestic and international regulatory registrations and submissions
Support regulatory approval of medical devices across product development, manufacturing, and clinical studies
Provide pre-market, post-market, physician-initiated study, compliance, and corporate regulatory support
Partner with Marketing and Development teams on marketed products, labeling, promotional materials, product changes, and approval documentation
Compile and submit documentation for marketing initiatives and review promotional materials for regulatory impact
Review packaging and labeling changes, translations, vendor documentation, certifications, and quality fitness
Represent Regulatory Affairs on project teams and in meetings concerning labeling and promotion
Assist with 510(k), IDE, PMA, PMA updates, CE Marking, Canadian, EU, and ROW registrations
Prepare submissions and reports for the FDA and other international regulatory agencies
Plan, create, organize, and interpret regulatory submission documents
Review and approve specifications, procedures, schedules, test protocols, reports, and validations
Evaluate and present change assessments and review, evaluate, and approve Engineering Change Orders

Requirements

What you’ll need

B.S. / B.A. or equivalent combination of education and experience
5+ years of regulatory medical device industry experience
Knowledge of regulatory guidelines and requirements (domestic and international)
RAC Certification preferred
Effective verbal and written communication skills
Experience with reviewing ECOs, Requirements, and Specification Documents
Understanding of 21 CFR 820, CMDR, ISO 13485, MDD
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

Benefits

Comp & perks

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