About the Opportunity

As Principal Regulatory Affairs Specialist, you will provide regulatory support and strategy development for product development from early feasibility through marketing authorization. You will work closely with internal departments to maintain compliance with regulatory requirements, support regulatory strategy development, and prepare documents for submission to global regulatory authorities, as required. You will provide direct support in the preparation and submission of global market authorizations, including license renewals and periodic updates, which allow the Company to legally market products both domestically and internationally.  

TTC*:

Responsibilities (General)

• • Regulatory Submissions & Liaison:
    • Prepare, review, and complete regulatory submissions to global regulatory agencies (e.g., FDA, Health Canada, Europe), and communicate with regulatory authorities throughout the development and review of submissions.
    • Define and execute global regulatory strategies across multiple regions (EU, US, APAC) for AI/ML devices, ensuring compliance with local and international standards.
    • Act as a liaison with regulatory authorities, ensuring appropriate channels of communication during submission development and review.
  • Regulatory Information Management & Compliance:
    • Organize regulatory information, track and control submissions, and review and advise on labeling to ensure compliance with regulatory filings.
    • Review product changes for impact on regulatory filings worldwide and provide guidance and advice to project teams on regulatory issues.
  • Regulatory Reporting & Licensing:
    • Support device reporting and compile and submit materials for license renewals, updates, and product registration changes.
  • Product Development Support & Regulatory Guidance:
    • Provide regulatory guidance and support to product development teams, ensuring compliance with relevant regulations and guidance from regulatory agencies.
    • Determine regulatory requirements for intended products and markets, advising on regulatory submission pathways and approval options.
  • Global Regulatory Compliance:
    • Ensure medical devices meet regulatory requirements and are developed according to global regulatory standards and state-of-the-art practices.
    • Proactively address regulatory landscape changes, particularly for AI/ML standards and Software as a Medical Device (SaMD) regulations.
  • Regulatory Intelligence & Policy Monitoring:
    • Monitor proposed rulemaking and final rules, assessing their potential impact on products, internal procedures, and regulatory strategies.
    • Stay informed about industry trends, emerging regulatory best practices, and regulatory compliance issues.
  • Mentorship & Development:
    • Mentor and develop senior regulatory professionals, guiding them through complex regulatory scenarios, including AI/ML medical device issues.

Requirements (General)

• • Education: B.S. or higher degree in a Life Science, Engineering or related discipline.
    • Regulatory Affairs Certification (RAC) preferred.
  • Demonstrated knowledge and experience in the identification and interpretation of 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.

• Principal Regulatory Affairs Specialist (Specific)

  • Experience: 
    • Minimum 3 years’ experience directly related to AI/ML-based medical devices or software as a medical device (SAMD)
  • Minimum 7 years of medical device experience in a regulatory affairs role.
  • Experience in global regulatory submittals and applications for medical devices (AI/ML SaMD preferred).
  • Experience in supporting External 3rd Party Audits and Inspections preferred.\