Full-Time
Regulatory Specialist
Updated on 4/18/2024
Provides whole body MRI scanning services
AI & Machine Learning
Compensation Overview
$65,000 - $80,000Annually
Mid, Senior
Remote in USA
Required Skills
Communications
Marketing
Requirements
- Bachelor of Science, Engineering, or Medical Technology
- Regulatory Affairs Certification (RAC) preferred
- Minimum of 5 years of international experience in medical device Regulatory Affairs
- Experience with Class I, II medical devices, MDDS, and CDS
- Authorship and implementation of a minimum of 20 standard operating procedures
- Experience managing post-market actions in the US
- Familiarity with FDA electronic submission platforms (e.g., eSTAR, FURLS)
- Experience with US/EU/Canada submissions
- Deep understanding of global regulatory standards and frameworks, including IEC 62304, 21CFR820, ISO 13485, ISO 14971, IEC 62366, FDA guidances, European MDR, Health Canada Medical Device regulations, and State/Provincial RA regulations
- Familiarity with regulatory requirements for medical device software, AI/ML-enabled devices, predetermined change control plans, and cybersecurity
- Proficiency in Quality System Regulations ISO 13485, recalls and corrections, and labeling requirements, with international experience being desirable
- Understanding of Class I, II medical devices, MDDS, and CDS
- Knowledge of FDA Q-submissions and electronic submission processes, as well as US/EU/Canada submissions processes
- Self-starter with strong independent work capabilities
- Effective time management and problem-solving skills
- Excellent interpersonal and collaborative abilities.
- Proficiency in conducting thorough research on regulatory requirements and executing end to end project-based tasks with tight deadlines
- Strong analytical skills and sound judgment
- Demonstrated organizational proficiency
- Clear and concise oral and written communication skills.
Responsibilities
- Prepare, submit, and update pre-submission packages, Q-sub/supplements/amendments & RA submission pathways compliant with 21CFR820, 21CFR892, and FDA guidance documents
- Prepare justifications for intended use, risk classifications, and substantial equivalence matrix
- Perform regulatory impact assessments of design changes
- Collaborate with cross-functional teams to develop DHF/RMF/DMR alongside SaMD development sprints
- Assist in developing eQMS processes, procedures, work instructions, and forms for the Regulatory department
- Develop eQMS for DHF/RMF/DMR, cybersecurity, software development, and app development
- Support front-room, desk audits, and site inspections by regulatory authorities
- Review, comment on, and approve change control requests affecting medical device marketing
- Complete letters to file following US FDA regulations and guidance
- Build and nurture relationships with external authorities, including US FDA, Health Canada, and Notified Bodies
- Complete all required training and maintain training plans and records
- Complete regional regulatory authority requests and provide requested documents
- Review, comment on, and approve labeling change requests, advertising, promotional requests, and field communications
- Execute, manage, and close post-market activities, including complaints, recalls, and corrections
- Prepare and submit all reporting activities associated with removals or corrections to US FDA and associated OUS Competent Authorities
- Assess standards changes and the impact of new and revised regulatory requirements
- Complete inquiries and requests from internal and external sources regarding regulatory processes and practices
- Support supervisor with any other requests for information and documentation associated with regulatory laws and regulations
Prenuvo offers comprehensive whole body MRI screening for early detection of various health conditions, including cancer, utilizing advanced scans and AI-augmented analysis for unparalleled diagnostic accuracy.
Company Stage
Series A
Total Funding
$71.8M
Headquarters
Redwood City, California
Founded
2018
Growth & Insights
Headcount