Senior Regulatory Affairs Specialist

🕒 August 13

🇺🇸 United States – Remote

💵 $99k - $129k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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iRhythm Technologies, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2006

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

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.

📋 Description

• Develop global, regional, and multi-country regulatory strategies for new and modified medical devices • Prepare international and domestic filings and registrations within established timelines and company objectives • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle • Interact with regulatory authorities during development and review to support submission approval • Represent Regulatory Affairs on assigned projects and provide regulatory guidance to 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 • Author or revise SOPs to improve Quality System regulatory compliance • Review and approve advertising and promotional materials for global labeling alignment and market-specific compliance • Support product recalls and communications for internationally commercialized products • Monitor the impact of changing global regulations on submission strategies and registrations • Perform other quality and regulatory-related duties as assigned

🎯 Requirements

• 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, including 21 CFR 820, MDD/CMDR, EU MDR, UKCA, Asia Pacific, and LATAM • Understanding of ISO 13485, ISO 14971, ISO 10993, GDPR, HIPAA, and other international regulations, directives, and standards highly preferred • Product development or sustaining/lifecycle management experience required • Exceptional written and oral communication skills • Exceptional problem-solving skills • Exceptional organizational skills • Willingness to travel up to 10% when required • Master’s or other advanced degree in a related field preferred • SaMD/MDSW, wearable, and OTC medical device experience highly preferred • Project management skills

🏖️ Benefits

• Medical, dental, and vision insurance starting on the first day • Paid holidays • PTO • 401K with company match • Employee Stock Purchase Plan • Paid parental leave • Pet insurance discount • Cultural Committee/Charity events • Reasonable accommodations for qualified individuals with disabilities in job application procedures