Senior Regulatory Affairs Manager – IVD Devices

CorDx; San Diego (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Comprehensive medical insurance

401(k) plan with generous companycon"

Flexible PTO

Job summary

CorDx Inc. is seeking an experienced Regulatory Affairs Manager in San Diego, CA to lead regulatory strategy and FDA submissions for IVD products throughout development and lifecycle.

You will collaborate with R&D, Clinical, Quality, and Manufacturing to ensure compliant product strategies and timing. The role requires at least five years of regulatory affairs experience in IVD/medical devices, hands‑on FDA submission work, and strong communication skills to coordinate across multiple teams.

Qualifications

• Bachelor’s degree required in Biology, Chemistry, Biomedical Engineering, Clinical Laboratory Science, Regulatory Science, Life Sciences, or related field.
• 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.

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) and CLIA related submissions.
• Coordinate cross‑functional submission activities and ensure documents are complete and on timeline.
• Manage FDA submission timelines, questions, and responses.
• Serve as regulatory point of contact for FDA communications; participate in FDA meetings.
• Coordinate responses to FDA deficiencies and information requests.
• Provide regulatory guidance for analytical and clinical study strategies supporting IVD submissions.
• Review analytical performance studies and clinical performance data; support strategies for POC and OTC products.

Skills

Regulatory strategy

FDA submission leadership

Technical writing

Regulatory writing

Cross‑functional leadership

Project management

Education

Bachelor’s degree or higher in Life Sciences or related field

Job description

CorDx Inc. is seeking an experienced Regulatory Affairs Manager in San Diego, CA to lead regulatory strategy and FDA submissions for IVD products throughout development and lifecycle.

You will collaborate with R&D, Clinical, Quality, and Manufacturing to ensure compliant product strategies and timing. The role requires at least five years of regulatory affairs experience in IVD/medical devices, hands‑on FDA submission work, and strong communication skills to coordinate across multiple teams.