Manager - Regulatory Affairs
New
I
iRhythmDigital healthcare
Remote - USFull-TimeManager
Salary127,000 - 165,000 USD per year
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Job Details
- Experience
- 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
- Required Skills
- Project ManagementCybersecurityRisk Management
Requirements
- BA or BS degree in engineering, life sciences, or a related field.
- 8-10 years of regulatory affairs experience with a Bachelor’s degree, or 6 years with a Master’s degree.
- Demonstrated competency in 21 CFR 820, EU MDD/MDR, ISO 13485, IEC 62304, ISO 14971, and HIPAA.
- Software as a Medical Device (SaMD) experience.
- New product development experience.
- Proven experience with 510(k) authorship and managing FDA review processes.
- Demonstrated competency in developing risk-based regulatory strategies.
- Strong project management, problem-solving, and organizational skills.
- Willingness to travel approximately 5-10%.
Responsibilities
- Develop and execute regulatory strategies for new and modified medical devices.
- Manage and mentor regulatory associates, including team planning and talent development.
- Lead FDA submissions (510(k) or pre-submissions), including for wearable and AI Software as a Medical Device (SaMD) products.
- Review and approve advertising/promotional materials and product design changes for regulatory compliance.
- Oversee EU MDR Technical Documentation and international submissions.
- Act as a regulatory subject matter expert in AI, SaMD, and Cybersecurity.
- Interact with regulatory authorities during submission and review processes.
- Monitor global regulation changes and update internal SOPs and processes.
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