iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias are clinically diagnosed by combining our wearable biosensing technology with powerful cloud-based data analytics and machine- learning capabilities. Our goal is to be the leading provider of first-line ambulatory ECG monitoring for patients at risk for arrhythmias. iRhythm’s continuous ambulatory monitoring has already put over 1 million patients and their doctors on a shorter path to what they both need – answers.
About this role:
iRhythm’s Regulatory Affairs team is looking for a strong candidate to fill the role of Senior Regulatory Affairs Specialist with experience in global regulatory affairs. This position provides an opportunity to be at the forefront of medical wearable technologies that is making a difference with patient outcomes and better healthcare.
As a Senior Regulatory Affairs Specialist with a fast growing, Class II/Class IIa software and hardware medical device company, you will be responsible for leading submissions from product development with project teams through regulatory clearance/approvals, and product life cycle support activities, including license renewals, development of global product registration strategies, and interactions with global regulatory agencies. You will independently organize regulatory information and apply advanced regulatory expertise to guide cross-functional partners through strategic and creative thinking.
Develop 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 merging issues throughout the product lifecycle
Negotiate 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 approval requirements
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 ensure regulatory compliance
Lead the regulatory requirements for product recalls and communications
Monitor impact of changing global regulations on submission strategies & registrations
Perform other quality and regulatory-related duties as assigned.
What’s in it for you:
This is a full-time position located in San Francisco, CA 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!
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.
BA or BS degree required
5 years minimum of medical device experience with US and/or EU class II or III devices
3 years minimum of regulatory experience with US and/or EU class II or III devices
Software as a medical device (SaMD) experience highly preferred
Wearable medical device experience preferred
Familiarity with global medical device regulations
Demonstrated competency of 21 CFR 820, MDD/CMDR, ISO 13485, ISO 14971, HIPAA and other international standards
EU MDR understanding highly preferred
Comprehensive knowledge with risk based decision making in the application to regulation compliance and business objectives
Strong project management skills
Exceptional problem-solving skills
Exceptional organizational skills
Exceptional communication (written and oral) skills
Willingness to travel when required, approximately 10%
Internal Number: 1071
About iRhythm Technologies, Inc.
iRhythm Technologies, Inc. is a publicly traded digital healthcare company redefining the way cardiac arrhythmias are clinically diagnosed by combining our wearable biosensing technology with cloud-based data analytics and machine- learning capabilities. [Nasdaq symbol: IRTC]
Our goal is to be the leading provider of first-line ambulatory electrocardiogram, or ECG, monitoring for patients at risk for arrhythmias. We have created a unique platform, ZIO by iRhythm, which we believe allows physicians to diagnose many arrhythmias more quickly and efficiently than traditional technologies, avoiding multiple indeterminate tests, allowing for appropriate medical intervention and potentially avoiding more serious downstream medical events, including stroke.
iRhythm’s continuous ambulatory monitoring has already put over 1 million patients and their doctors on a shorter path to what they both need – answers.