Personalized precision heart health
Principal Regulatory Affairs Specialist
Location
California + 2 moreAll locations: California, New York, Texas
Posted
8 days ago
Salary
$195.5K - $218.5K / year
Seniority
Lead
Job Description
Job Requirements
- B.S. or higher degree in a Life Science, Engineering or related discipline.
- Regulatory Affairs Certification (RAC) preferred.
- Minimum 7 years of medical device experience in a regulatory affairs role.
- Minimum 3 years’ experience directly related to AI/ML-based medical devices or software as a medical device (SAMD) preferred.
- Experience in global regulatory submittals and applications for medical devices (AI/ML SaMD preferred).
- Experience supporting External 3rd Party Audits and Inspections preferred.
- Demonstrated knowledge and experience in identifying and interpreting global regulations, guidelines, and compliance. Must be able to independently coordinate and oversee interdisciplinary project team in quality and timely delivery and compilation and retention of submission documents.
- Excellent organizational, writing, and verbal communication skills.
Benefits
- XX% target annual bonus
- Stock options
- Paid benefits
- Employee perks
- Flexible remote work options
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