Manager, Regulatory Affairs

iRhythm Technologies, Inc.; San Francisco (CA); Remote; USD 127,000 - 165,000; Full time

Benefits offered by this job

Competitive salary package

Medical, dental, and vision insurance

401(k) with company match

Paid holidays and time off

Employee Stock Purchase Plan

Job summary

A leading medical technology firm is seeking a Regulatory Affairs professional to develop and execute regulatory strategies for innovative medical devices. The ideal candidate will have 8-10 years of experience in US and/or EU regulatory affairs, particularly in Software as a Medical Device (SaMD). This full-time position offers a competitive salary package and excellent benefits including medical, dental, vision insurance, and a 401(k) plan with company match. This position is remote, allowing flexibility in managing work-life balance.

Qualifications

• 8-10 years of US/EU regulatory affairs experience required.
• Demonstrated competency in medical device regulations such as 21 CFR 820.
• Experience with Software as a Medical Device (SaMD).

Responsibilities

• Develop regulatory strategies for medical devices.
• Lead FDA submissions and regulatory expert tasks.
• Prepare regulatory filings in line with project timelines.

Skills

Regulatory affairs

Problem-solving

Organization

Communication

Project management

Risk-based regulatory strategies

Regulatory submissions

Audit support

Travel willingness

Education

BA or BS degree in engineering or life sciences

Tools

Regulatory compliance manuals

Quality management systems

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 [e-mail].

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.