Regulatory Affairs Manager – AI SaMD & Wearables

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

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.