Associate Regulatory Affairs Manager (Atlanta)

Associate Regulatory Affairs Manager (San Diego)

Who is CorDx？ CorDx 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 Type: Full time Job Title: Associate Regulatory Affairs Manager Location: Onsite - San Diego, CA Position Summary: 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. Key Responsibilities: Assist in the preparation, review, and submission of regulatory documentation for new products, product changes, and ongoing compliance. Support the regulatory submission process for 510(k), Technical Files, and other regulatory filings. Provide regulatory guidance to cross-functional teams during product development and post-market activities under the direction of senior management. Help track and manage submission timelines, regulatory project plans, and documentation. Stay informed on changes in FDA, ISO 13485, IVDR, and other global regulations, communicating relevant updates to the team. Conduct regulatory assessments for product modifications and assist in defining appropriate submission strategies. Participate in internal and external audits, inspections, and regulatory agency communications as assigned. Contribute to the maintenance of regulatory files and submission records in accordance with internal procedures and regulations. May provide oversight and mentorship to junior staff or specialists on assigned projects. Requirements Education: Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field. Master’s degree preferred. Professional Experience: 4–6 years of regulatory affairs experience in the medical device or IVD industry. Experience supporting or managing 510(k) submissions and regulatory filings. Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and international medical device regulations. Experience participating in regulatory audits and inspections preferred. Skills & Competencies: Strong organizational, document management, and project coordination skills. Excellent communication, problem-solving, and cross-functional collaboration abilities. Detail-oriented with the ability to manage multiple regulatory projects and priorities. Proficient in Microsoft Office and regulatory document management systems. Ability to work independently and proactively while seeking guidance for complex issues. Benefits Highly competitive compensation package. Comprehensive medical, dental, and vision insurance. 401(k) plan with generous company contributions. Flexible paid time off (PTO) policy. Additional substantial benefits. 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.

San Diego, CA, USA

Negotiable Salary

Workable

Regulatory & Compliance Specialist

Who is CorDx？ CorDx 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 Type: Full time Job Title: Regulatory & Compliance Specialist Location: Onsite - San Diego Salary Range: $90,000 - $95,000 Position Summary: The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and quality standards. This role will work closely with cross-functional teams to support product development, manufacturing, and post-market activities. The specialist will ensure that all documentation and files related to diagnostic development are completed in a timely manner and are ready for inspections. Key Responsibilities: Ensure compliance with regulatory requirements for In Vitro Diagnostic products, FDA 21 CFR Part 820, ISO 13485. Provide regulatory guidance during the product development process, ensuring that products are designed and developed in compliance with applicable regulations. Participate in risk management activities, including the development and maintenance of risk management files according to ISO 14971 and FDA 21 CFR Part 820. Conduct risk assessments and work with product development teams to mitigate identified risks. Participate in design reviews meetings and validation activities, ensuring that regulatory and quality requirements are met. Review and approve design control documentation, including design input and output, design verification and validation protocols, ensuring that all documentation meets regulatory requirements. Review and approve design history file for each new product. Support preparation of internal quality and regulatory documents in support of regulatory submission (De Novo and 510K) for IVD products. Requirements Education: Bachelor's degree in a related field (e.g., Life Sciences, Engineering, Regulatory Affairs, Quality Management) or equivalent experience. Advanced degree or certification in Regulatory Affairs (e.g., RAC) or Quality Management (e.g., CQE, CQA) is a plus. Experience: 3+ years of experience in regulatory affairs, quality assurance, or compliance within the medical device or In Vitro Diagnostics industry. Experience with regulatory submissions, including 510(k) and CE marking, is highly preferred. Strong knowledge of global regulatory standards, including FDA regulations and ISO 13485. Skills: Strong understanding of IVD product development and manufacturing processes. Excellent written and verbal communication skills Strong analytical and problem-solving skills, with attention to detail and accuracy. Ability to work independently and as part of a team, with strong organizational and time-management skills. High level of integrity and commitment to upholding regulatory and quality standards. Proactive approach to identifying and addressing compliance risks and issues. Benefits Medical Insurance Plan Retirement Plan Paid Time Off 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.

San Diego, CA, USA

$90,000-95,000/year

Associate Regulatory Affairs Manager (Atlanta)

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