Senior Regulatory Affairs Specialist

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:

About this role:

iRhythm's Regulatory Affairs team is looking for a strong candidate to fill the role of Senior Regulatory Affairs Specialist with global regulatory expertise. This position provides an opportunity to be at the forefront of medical wearable and artificial intelligence technologies that are making a difference with patient outcomes and better healthcare.

As a remote Senior Regulatory Affairs Specialist with a fast growing, AI software and wearable hardware medical device company, you will be responsible for working with cross functional teams to assess market requirements, develop global product registration strategies, help guide project teams from preparation to submission and through successful dossier reviews with various regulatory agencies to gain and maintain product registrations. You will independently organize regulatory information and apply regulatory expertise to guide cross-functional partners by strategic and creative thinking.

Our work environment is fast-paced, with a collaborative atmosphere. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient experience. We are looking for like-minded individuals to join our team today!

Specific job responsibilities include:

• Develops sound global, regional, and multi-country regulatory strategies for new and modified medical devices
• Prepare international and domestic filings/registrations to established timelines and company objectives
• Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle
• Interact with regulatory authorities during the development and review process to ensure submission approval
• Represent Regulatory Affairs on assigned projects and provide regulatory guidance to the cross-functional teams
• Coordinate with international contacts on product changes, regulatory notifications and registration/license maintenance
• Review and approve product design changes to maintain regulatory compliance for significant changes
• Author or revise SOPs to improve regulatory compliance of the Quality System
• Review and approve advertising and promotional items to drive global labeling alignment as well as market-specific regulatory compliance
• Support product recalls and communications for internationally commercialize products

• Monitor impact of changing global regulations on submission strategies & registrations
• Perform other quality and regulatory-related duties as assigned.

About you:

Required Qualifications

• Bachelor's degree (B.A./B.S. required);
• 3 years of Regulatory Affairs experience in the medical device industry
• Familiarity with global medical device regulations; 21 CFR 820, MDD/CMDR, EU MDR, UKCA, ASIA PAC, LATAM, etc. highly preferred
• Demonstrated understanding of ISO 13485, ISO 14971, ISO 10993, GDPR, HIPAA and other international regulations/directives/standards highly preferred
• Product development or sustaining/life cycle management experience required
• Exceptional communication (written and oral) skills
• Exceptional problem-solving skills
• Exceptional organizational skills
• Willingness to travel when required, up to 10%

Preferred Qualifications

• Master's or other advanced degree in a related field preferred
• SaMD/MDSW, wearable, and OTC medical device experience highly preferred
• Project management skills

What's in it for you:

This is a full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurance (all of which start on your first day), paid holidays, and PTO!

iRhythm also provides additional benefits including 401K (with company match), an Employee Stock Purchase Plan, paid parental leave, pet insurance discount, Cultural Committee/Charity events, and so much more!

FLSA Status: Exempt

As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer (M/F/V/D). Pursuant to San Francisco Fair Chance Ordinance, we will consider for employment all qualified applicants with arrest and conviction records.

Make iRhythm your path forward.

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Location:

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

Estimated Pay Range

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