Manager, Regulatory Affairs
New
I
iRhythmMedical Devices
United StatesFull-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 Management
Requirements
- Bachelor's degree in engineering, life sciences, or a related field.
- 8-10 years of US/EU regulatory affairs experience with a Bachelor’s degree, or 6 years with a Master’s degree.
- Experience with Software as a Medical Device (SaMD) and new product development.
- Proven expertise in authoring 510(k)s and managing FDA review processes.
- Demonstrated competence in 21 CFR 820, EU MDD/MDR, ISO 13485, IEC 62304, ISO 14971, and HIPAA.
- Demonstrated ability to develop risk-based regulatory strategies.
- Strong project management, problem-solving, and organizational skills.
- Excellent written and oral communication skills.
- Ability to travel approximately 5-10% of the time.
Responsibilities
- Develop and execute regulatory strategies for new and modified medical devices.
- Manage regulatory associates, including work planning, guidance, and talent development.
- Lead FDA submissions, including 510(k) and pre-submissions for wearable and AI SaMD products.
- Review and approve advertising and promotional materials for regulatory compliance.
- Lead EU MDR Technical Documentation and international regulatory filings.
- Establish regulatory processes for AI, SaMD, and cybersecurity.
- Author or revise SOPs to improve quality system compliance.
- Monitor global regulatory impacts on submission and registration strategies.
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