WHO IS CORDX？

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

JOB SUMMARY:

CorDx Inc. is seeking a highly skilled and experienced Director of Regulatory Affairs to lead 510(k) submissions for our IVD products. This role is responsible for overseeing regulatory strategies, FDA interactions, and compliance efforts to ensure the successful and timely market clearance of new and existing products. The ideal candidate will possess in-depth knowledge of the 510(k) submission process, regulatory risk assessment, and cross-functional collaboration to support business objectives.

REQUIREMENTS

• Bachelor’s or Master’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, or a related field.
  Minimum of 8-10 years of experience in IVD or medical device regulatory affairs, with a strong focus on 510(k) submissions.
  Extensive knowledge of FDA 510(k) submission requirements, pre-submission meetings (Q-Sub), and post-market requirements.
  Proven experience in preparing and submitting successful 510(k) applications and responding to FDA inquiries (AI Letters, Interactive Reviews, etc.).
  Strong understanding of regulatory frameworks, including 21 CFR Part 807, ISO 13485, IVDR, and CLIA requirements.
  Experience leading interactions with the FDA, including regulatory negotiations and Q-Sub meetings.
  Excellent project management skills, with the ability to oversee multiple regulatory submissions simultaneously.
  Strong technical writing skills, with the ability to compile complex scientific and regulatory data into clear, concise submissions.
  Ability to work cross-functionally with internal teams and external regulatory bodies.

PREFERRED SKILLS

RAC certification or similar.

• Lead and manage the entire 510(k) submission process, including preparation, compilation, review, and submission to the FDA for IVD products.
• Oversee all aspects of regulatory submissions, including Traditional, Special, and Abbreviated 510(k)s, ensuring completeness and compliance with 21 CFR 807 and FDA guidance.
• Develop and execute regulatory strategies to achieve successful 510(k) clearance in alignment with business timelines.
• Conduct regulatory gap assessments to determine appropriate pathways and data requirements for submission.
• Ensure regulatory submissions contain all required elements, including:
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• Device Description & Intended Use

• Predicate Device Comparisons
• Performance Testing (Analytical & Clinical Data)
• Risk Management Documentation
• Software & Cybersecurity Documentation (if applicable)
• Labeling & IFU Compliance
• Maintain proactive communication with the FDA, including responding to Requests for Additional Information (AI Letters) and leading pre-submission (Q-Sub) meetings as needed.
• Work closely with R&D, Quality, Clinical, and Manufacturing teams to gather and validate technical and performance data for regulatory submissions.
• Conduct regulatory risk assessments and implement mitigation strategies to ensure compliance with evolving FDA regulations.
• Stay updated on regulatory changes, new FDA guidance documents, and enforcement trends to adapt submission strategies accordingly.
• Oversee post-market regulatory compliance, including device modifications, change assessments, and follow-up regulatory filings.
• Review and approve labeling, promotional materials, and product claims to ensure compliance with FDA and global regulatory requirements.
• Mentor and train regulatory team members on 510(k) submission best practices and regulatory compliance.
  Base Pay Range $100000-$200000/Yearly
  Package include: Base Pay+Job skills+Bonus+Commission