Manager, Regulatory Affairs

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

Career-defining. Life-changing.

At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you: curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career.

About This Role

Responsibilities

• 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 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.
• New product development 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.
• Wearable medical device experience preferred.
• Familiarity with global medical device regulations (LATAM, Asia Pac, EMEA, etc.) preferred.
• Audit support experience preferred.
• Strong project management skills.
• Exceptional problem‑solving skills.
• Exceptional organizational skills.
• Exceptional communication (written and oral) skills.
• Willingness to travel when required, approximately 5‑10%.

What's in it for You

This is a full‑time position with a competitive salary package and excellent benefits including medical, dental and vision insurance, paid holidays and paid time off. iRhythm also provides additional benefits such as a 401(K) with company match, an Employee Stock Purchase Plan, and annual organizational/cultural committee events.

Estimated Pay Range: $127,000.00 – $165,000.00

Location

Remote – US

As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. 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.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at [e-mail].