Manager, Regulatory Affairs
New
I
iRhythmMedical devices
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
- HIPAA
Requirements
- Hold a BA or BS degree in engineering, life sciences, or a related field.
- Have 8–10 years of US and/or EU regulatory affairs experience with a bachelor’s degree, or at least 6 years with a master’s degree.
- Demonstrate competency with 21 CFR 820, EU MDD/MDR, ISO 13485, IEC 62304, ISO 14971, HIPAA, and other medical device industry standards.
- Have software as a medical device (SaMD) experience.
- Have new product development experience.
- Have authored 510(k)s and managed FDA reviews to gain clearance.
- Demonstrate competency in developing risk-based regulatory strategies.
- Bring strong project management, problem-solving, organizational, and written and oral communication skills.
- Wearable medical device experience is preferred.
- Familiarity with global medical device regulations and audit support experience are preferred.
- Be willing to travel approximately 5–10% when required.
Responsibilities
- Develop and execute regulatory strategies for new and modified medical devices in line with business objectives.
- Manage regulatory associates, including work planning, guidance, execution, and talent development.
- Lead FDA 510(k) and pre-submissions for wearable devices and SaMD products.
- Review and approve advertising and promotional materials for regulatory compliance.
- Lead EU MDR technical documentation and other international submissions for wearable devices and SaMD.
- Develop regulatory tools and matrices to enhance team efficiency and capabilities.
- Lead regulatory work on AI, SaMD, and cybersecurity, collaborating with stakeholders to establish compliance processes.
- Prepare domestic and international regulatory filings and registrations according to project timelines.
- Interact with regulatory authorities during development and review to obtain submission clearance.
- Review product design changes, revise SOPs, monitor regulatory changes, and support internal and external audits.
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