Regulatory Specialist
Posted on 3/15/2024
Prenuvo

51-200 employees

Whole body MRI screening with AI-augmented analysis
Company Overview
Prenuvo stands out in the health tech industry as a global leader in whole body MRI screening, leveraging advanced imaging technology and AI-augmented analysis for early detection of major health diseases. The company's commitment to empowering individuals with comprehensive and detailed scans promotes informed health decisions, while their use of AI in creating consistent, reliable reports sets a new standard in diagnostic accuracy. This proactive approach to health screening, coupled with their dedication to improving accessibility to significant clinical insights, positions Prenuvo as a company that truly values the longevity and quality of its clients' lives.
AI & Machine Learning

Company Stage

Series A

Total Funding

$71.8M

Founded

2018

Headquarters

Redwood City, California

Growth & Insights
Headcount

6 month growth

28%

1 year growth

98%

2 year growth

204%
Locations
Remote
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
Marketing
CategoriesNew
Legal
Risk & Compliance
Legal & Compliance
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