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
