Regulatory Affairs Manager - IVD

CorDx•San Diego, CA

5d•Onsite

About The Position

CorDx Inc. is seeking an experienced Regulatory Affairs Manager to support the development, registration, and lifecycle management of in vitro diagnostic (IVD) medical devices in the United States. The Regulatory Affairs Manager will lead regulatory strategy and submissions for diagnostic products, including FDA 510(k), CLIA categorization/waiver activities, and other applicable regulatory pathways. The position will work closely with R&D, Clinical Affairs, Quality, Manufacturing, Product Management, and external partners throughout the product development lifecycle.

Requirements

Bachelor’s degree or higher in Biology, Chemistry, Biomedical Engineering, Clinical Laboratory Science, Regulatory Science, Life Sciences, or a related scientific discipline.
Minimum 5 years of Regulatory Affairs experience in the IVD, medical device, diagnostics, or related regulated healthcare industry.
Hands-on experience preparing and supporting FDA regulatory submissions.
Strong knowledge of FDA medical device and IVD regulatory requirements.
Experience reviewing technical documentation, analytical performance studies, clinical performance data, and product labeling.
Demonstrated ability to manage regulatory projects independently and work effectively across multiple functions.
Excellent technical writing, analytical, organizational, and communication skills.
Ability to manage multiple regulatory projects and deadlines simultaneously.

Nice To Haves

Direct experience with IVD products and FDA 510(k) submissions.
Experience serving as the primary or key regulatory contact during FDA review.
Experience preparing FDA Additional Information responses and participating in interactive review.
Experience with CLIA Waiver and/or CLIA Categorization submissions.
Experience with point-of-care (POC) and/or over-the-counter (OTC) IVD products.
Experience with infectious disease, respiratory, toxicology, reproductive health, or rapid diagnostic products.
Experience with FDA Q-Submissions/Pre-Submissions.
Experience with De Novo submissions is a plus.
Familiarity with ISO 13485, ISO 14971, design controls, and applicable FDA Quality System requirements.
RAC certification is a plus.

Responsibilities

Develop and execute U.S. regulatory strategies for new and existing IVD products.
Determine appropriate regulatory pathways, product classification, predicate devices, and submission requirements.
Provide regulatory guidance to R&D, Clinical, Quality, Manufacturing, and Product teams throughout product development.
Participate in design and development activities and provide regulatory input regarding intended use, indications for use, labeling, performance requirements, and regulatory testing.
Conduct regulatory assessments for product changes and determine whether new regulatory submissions or notifications are required.
Lead preparation, review, and submission of FDA regulatory applications, including: 510(k) Premarket Notifications, CLIA Categorization and CLIA Waiver submissions, Q-Submissions / Pre-Submissions, Additional Information (AI) responses, and 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.
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.
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.
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.
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.