Regulatory Affairs Lead, AI SaMD & Wearables (Remote)

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

Benefits offered by this job

Medical, dental, and vision insurance

Paid holidays and paid time off

401(K) with company match

Employee Stock Purchase Plan

Job summary

A leading medical device company is seeking a Regulatory Affairs Specialist to develop and execute strategies for medical devices, including wearable technology. The role requires 8-10 years of experience in US and EU regulatory affairs and strong project management skills. You will lead FDA submissions and interact with regulatory authorities to ensure compliance. This full-time position offers a competitive salary and excellent benefits, including medical, dental, and a 401(K) plan.

Qualifications

• 8-10 years of US/EU regulatory affairs experience.
• Experience with 21 CFR 820 and EU MDD/MDR standards.
• Software as a medical device (SaMD) experience required.

Responsibilities

• Develop and execute regulatory strategies for medical devices.
• Lead FDA submissions including wearable devices.
• Manage regulatory associates and processes.

Skills

Regulatory strategy

Project management

Problem-solving

Communication skills

Education

BA or BS degree in engineering, life sciences, or related field

Job description

A leading medical device company is seeking a Regulatory Affairs Specialist to develop and execute strategies for medical devices, including wearable technology. The role requires 8-10 years of experience in US and EU regulatory affairs and strong project management skills. You will lead FDA submissions and interact with regulatory authorities to ensure compliance. This full-time position offers a competitive salary and excellent benefits, including medical, dental, and a 401(K) plan.