layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Regulatory Affairs Manager - IVD at CorDx | LAYIQ

510(k) Premarket Notifications
CLIA Categorization and CLIA Waiver submissions
Q-Submissions / Pre-Submissions
Additional Information (AI) responses
Other FDA submissions and regulatory correspondence as applicable
Prepare and review regulatory submission sections covering device description, labeling, analytical performance, clinical performance, software, usability, risk management, and other applicable areas.
Coordinate cross-functional submission activities and ensure submission documents are complete, consistent, accurate, and submitted according to project timelines.
Manage FDA submission timelines, commitments, questions, and responses.
Serve as a regulatory point of contact for communications with FDA reviewers.
Participate in FDA meetings, teleconferences, and interactive reviews.
Coordinate and prepare responses to FDA deficiencies and requests for additional information.
IVD Performance & Clinical Regulatory Support
Provide regulatory guidance for analytical and clinical study strategies supporting IVD submissions.
Review analytical performance protocols and reports, including studies such as: Limit of Detection (LoD)
Inclusivity and cross-reactivity
Interference
Precision and reproducibility
Stability
Flex studies
Method comparison
Clinical performance studies
Work closely with Clinical Affairs to ensure clinical study designs and resulting data meet FDA submission requirements.
Review clinical performance results, including PPA, NPA, confidence intervals, invalid rates, and other applicable performance measures.
Support regulatory strategies for POC and OTC diagnostic products and CLIA Waiver applications.
Labeling & Lifecycle Management
Review and approve regulatory aspects of: Instructions for Use (IFU)
Package labeling
Quick Reference Instructions
Product claims
Marketing and promotional materials
Ensure product claims and labeling remain consistent with FDA-cleared intended use and indications.
Maintain regulatory documentation and submission records.
Support post-clearance product changes and regulatory impact assessments.
Monitor relevant FDA regulations, guidance documents, standards, and industry developments affecting CorDx products.
Cross-Functional & Compliance Support
Partner with Quality Assurance to maintain compliance with applicable FDA Quality System requirements and internal procedures.
Participate in design reviews, risk management activities, CAPA investigations, and change control activities when regulatory input is required.
Support FDA inspections and other regulatory audits.
Develop and maintain regulatory SOPs, work instructions, templates, and regulatory tracking systems.
Provide regulatory training and guidance to internal teams.
Mentor junior Regulatory Affairs staff and support development of the regulatory team.

Regulatory Affairs Manager - IVD

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