Cordx
Associate Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)
San Diego, California, United States · Full-time
Sponsorship not specifiedDetected 377 days ago
Data ScienceComplianceProduct ManagementFDA RegulatoryMedical DevicesCommunicationCollaborationProblem SolvingMentoringMicrosoft OfficeRegulatory Affairs
> stay_score
odds of building a lasting career here
16Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
No strong sponsorship signal in the public record yet. In the full product we resolve the exact legal entity and show its filing history with a confidence score — treat as unverified until then.
Lottery odds assume a STEM candidate.
Personalize to your clock →> community_outcomes
No reports yet — be the first to help the next applicant.
About the role
- The Associate Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device and IVD products.
- This role will assist in managing regulatory projects, ensuring compliance with FDA, ISO 13485, and other global regulatory requirements.
- The Associate Manager will work cross-functionally with internal teams and external partners to support product approvals and maintain regulatory compliance throughout the product lifecycle.
Responsibilities
- Support the regulatory submission process for 510(k), Technical Files, and other regulatory filings.
- Help track and manage submission timelines, regulatory project plans, and documentation.
- Strong organizational, document management, and project coordination skills.
Requirements
- Master's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field.
Nice to have
- Experience participating in regulatory audits and inspections preferred.
Benefits
- Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health.
- 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.
Company info
- Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity.
Equal opportunity
- Statement: We are an equal opportunity employer committed to inclusion and diversity.
- We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.
This listing is sourced directly from Cordx's careers page and normalized into a canonical job model.