About this opportunity
iRhythm Technologies, Inc. lists this Manager, Regulatory Affairs opportunity in san francisco, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
About This Role
Responsibilities include:
Developing and executing regulatory strategies for new and modified medical devices in line with business objectives
Manage regulatory associates as needed, responsible for team's work planning, guidance, execution and talent development
Lead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products
Key Regulatory SME and review & approve advertising and promotional materials to ensure regulatory compliance
Regulatory strategy and processes for product life cycle management
Lead EU MDR Technical Documentation and other international submissions for both wearable devices and SaMD
Developing regulatory tools and matrices to enhance team efficiency and capabilities as needed
Lead regulatory expert in AI, SaMD, Cybersecurity, collaborating with stakeholders establishing necessary processes to ensure regulation compliance
Preparing international and domestic regulatory filings/registrations in line with established project timelines
Interacting with regulatory authorities during the development and review process to ensure submission clearance
Review and approve product design changes to maintain regulatory compliance for significant changes
Author or revise SOPs to improve regulatory compliance within the Quality System
Monitoring the impact of changing global regulations on submission strategies & registrations
Support external and internal audits
Perform other regulatory-related duties as assigned.
About you
BA or BS degree in engineering, life sciences, or a related field required.
8-10 years minimum of US and/or EU regulatory affairs experience with a Bachelor's degree; 6 years minimum of US and/or EU regulatory affairs experience with a Master's degree
Demonstrated competency in operating under 21 CFR 820, EU MDD/MDR, ISO 13485, IEC 62304, ISO 14971, HIPAA and other medical device industry standards
Software as a medical device (SaMD) experience required
Authorship of 510(k)s and experience with management of FDA reviews to gain clearance required
Demonstrated competency in developing risk based regulatory strategies required
Familiarity with global medical device regulations (LATAM, Asia Pac, EMEA, etc.) preferred
Audit support experience preferred
Exceptional problem‑solving skills
Exceptional organizational skills
Exceptional communication (written and oral) skills
Willingness to travel when required, approximately 5‑10%
New product development experience required
Wearable medical device experience preferred
Strong project management skills
What's in it for you
This is a full-time position with competitive salary package and excellent benefits including medical, dental and vision insurance, paid holidays and paid time off. iRhythm also provides additional benefits including 401(k) (w/ company match), an Employee Stock Purchase Plan, annual organizational/cultural committee events and more!
Location
Remote - US
Estimated Pay Range
$127,000.00 - $165,000.00
Actual compensation may vary depending on job‑related factors including knowledge, skills, experience, and work location.
Equal Opportunity Employer
iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.
We provide reasonable accommodations for qualified individuals with disabilities in job application procedures. If you need an accommodation, contact us at .
About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud‑based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm's vision is to deliver better data, better insights, and better health for all.
Make iRhythm your path forward
Zio, the heart monitor that changed the game.
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Worksite address
san francisco, CA, 94199, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.