Senior Regulatory Affairs Specialist

iRhythm Technologies, Inc.

Senior Regulatory Affairs Specialist guiding global registrations for iRhythm’s wearable cardiac-monitoring and AI healthcare technologies. Developing filings, regulatory strategies, and compliance guidance across product lifecycles.

Posted 8/13/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $99,000 - $129,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing regulatory strategies for medical devices, ensuring compliance with global regulations, and effectively communicating with regulatory authorities. Proficient in managing product lifecycle and quality systems while providing guidance to cross-functional teams.

Highest-signal resume keywords

Regulatory Affairs ExperienceGlobal Medical Device RegulationsISO 13485 ComplianceProject Management SkillsProduct Development Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentFiling and Registration PreparationSOP Authoring and RevisionProduct Design Change ReviewQuality System Compliance

Soft Skills

Exceptional Written CommunicationExceptional Oral CommunicationExceptional Problem-SolvingExceptional Organizational Skills

Certifications & Qualifications

Bachelor’s DegreeMaster’s Degree Preferred

Industry Keywords

21 CFR 820MDD/CMDREU MDRUKCAISO 14971ISO 10993GDPRHIPAASaMD/MDSW ExperienceOTC Medical Device Experience

About the role

Key responsibilities & impact

Develop global, regional, and multi-country regulatory strategies for new and modified medical devices
Prepare international and domestic filings and registrations within established timelines and company objectives
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle
Interact with regulatory authorities during development and review to support submission approval
Represent Regulatory Affairs on assigned projects and provide regulatory guidance to cross-functional teams
Coordinate with international contacts on product changes, regulatory notifications, and registration/license maintenance
Review and approve product design changes to maintain regulatory compliance
Author or revise SOPs to improve Quality System regulatory compliance
Review and approve advertising and promotional materials for global labeling alignment and market-specific compliance
Support product recalls and communications for internationally commercialized products
Monitor the impact of changing global regulations on submission strategies and registrations
Perform other quality and regulatory-related duties as assigned

Requirements

What you’ll need

Bachelor’s degree (B.A./B.S.) required
3 years of Regulatory Affairs experience in the medical device industry
Familiarity with global medical device regulations, including 21 CFR 820, MDD/CMDR, EU MDR, UKCA, Asia Pacific, and LATAM
Understanding of ISO 13485, ISO 14971, ISO 10993, GDPR, HIPAA, and other international regulations, directives, and standards highly preferred
Product development or sustaining/lifecycle management experience required
Exceptional written and oral communication skills
Exceptional problem-solving skills
Exceptional organizational skills
Willingness to travel up to 10% when required
Master’s or other advanced degree in a related field preferred
SaMD/MDSW, wearable, and OTC medical device experience highly preferred
Project management skills

Benefits

Comp & perks

Medical, dental, and vision insurance starting on the first day
Paid holidays
PTO
401K with company match
Employee Stock Purchase Plan
Paid parental leave
Pet insurance discount
Cultural Committee/Charity events
Reasonable accommodations for qualified individuals with disabilities in job application procedures