Regulatory Affairs Manager

Manager, Regulatory Affairs

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 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
• 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 competitive salary package and excellent benefits including medical, dental and vision insurance, paid holidays and paid time off.

iRhythm also provides additional benefits including 401K (w/ company match), an Employee Stock Purchase Plan, annual organizational/cultural committee events and more!

Location

Remote - US

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range

$127,000.00 - $165,000.00

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 taops@irhythmtech.com

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.

There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact taops@irhythmtech.com. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.

For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121

Key skills/competency

• Regulatory Strategy
• FDA Submissions (510(k), Pre-submissions)
• Software as a Medical Device (SaMD)
• EU MDR Technical Documentation
• Medical Device Regulations (US/EU)
• Product Life Cycle Management
• AI/Cybersecurity Compliance
• SOP Development
• Risk Management (ISO 14971)
• Project Management