CorDx
Overview
CorDx is 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.
Key Responsibilities
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:
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 .
Compensation Base Pay Range: $100,000–$200,000 per year.
Package includes: Base Pay + Job skills + Bonus + Commission
Qualifications
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.
Benefits
RAC certification or similar.
Health Care Plan (Medical)
401K
Paid Time Off and Paid Sick Leave
Training & Development
We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.
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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.
Key Responsibilities
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:
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 .
Compensation Base Pay Range: $100,000–$200,000 per year.
Package includes: Base Pay + Job skills + Bonus + Commission
Qualifications
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.
Benefits
RAC certification or similar.
Health Care Plan (Medical)
401K
Paid Time Off and Paid Sick Leave
Training & Development
We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.
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