Staff Regulatory Affairs Specialist

5 days ago

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iRhythm Technologies, Inc.

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iRhythm Technologies, Inc. is a medical technology company that specializes in digital healthcare solutions for the management of cardiac arrhythmias. The company is best known for its ZioSuite, a comprehensive platform designed to deliver a streamlined solution for assessing heart health through advanced analytics and patient-centered data collection. iRhythm focuses on improving patient outcomes and optimizing the efficiency of healthcare providers through innovative technology in the cardiac monitoring space.

mHealth • Wearables • Digital Health • Medical Devices • technology

1001 - 5000 employees

Founded 2006

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

•At iRhythm, we are dedicated, self-motivated, and driven to do the right thing for our patients, clinicians, and coworkers. •Our leadership is focused and committed to iRhythm’s employees and the mission of the company. •We are better together, embrace change and help one another. We are Thinking Bigger and Moving Faster. •iRhythm is currently seeking an experienced Staff Regulatory Affairs Specialist. •This can be a remote or local position and an opportunity to be at the forefront of medical wearable and artificial intelligence technologies. •As a Staff Regulatory Affairs Specialist, you will be responsible for working with cross functional teams to assess and develop global product registration strategies. •Help guide project teams from preparation to submission and through successful dossier reviews with global regulatory agencies to gain and maintain international product registrations. •You will independently organize regulatory information and apply advanced regulatory expertise to guide cross-functional partners through 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!

🎯 Requirements

•8-10 years of regulatory affairs or relevant experience with a Bachelor’s degree (B.A./B.S. required) •6 years’ experience with Master’s or other advanced degree in related field •Lead and/or author 510k or MDR submission experience required •Software as a medical device (SaMD) experience highly preferred •AI/ML experience on ECG, sleep and/or physiologic signal monitoring highly preferred •Wearable and OTC medical device experience preferred •Familiarity with global medical device regulations; 21 CFR 820, MDD/CMDR, EU MDR, 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 experience highly preferred •Strong project management skills •Exceptional problem-solving skills •Exceptional organizational skills •Exceptional communication (written and oral) skills •Willingness to travel when required, up to 10%

🏖️ Benefits

•Competitive compensation package •Excellent benefits including medical, dental, and vision insurances (all of which start on your first day) •Health savings account employer contributions (when enrolled in high deductible medical plan) •Cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts) •Travel reimbursement for medical care •Noncontributory basic life insurance & short/ long term disability •Emotional health support for you and your loved ones •Legal / financial / identity theft/ pet and child referral assistance •Paid parental leave, paid holidays, travel assistance for personal trips and PTO! •401(k) (with company match) •Employee Stock Purchase Plan •Pet insurance discount •Unlimited amount of LinkedIn Learning classes and so much more!