CorDx
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Who Is CorDx?
CorDx is a multi-national biotech organization focused on innovation and supply in global health. With over 2,100 employees worldwide, serving millions in over 100 countries, CorDx provides rapid testing and point-of-care medical devices for detecting infectious diseases such as COVID-19, pregnancy, drugs of abuse, and biomarkers. The company is at the forefront of technology, artificial intelligence, and data science, aiming to deliver diagnostic solutions for critical healthcare questions. Job Description
We are seeking a highly motivated and experienced Regulatory Specialist to join our Regulatory Affairs team. The ideal candidate will have a strong background in IVD (In Vitro Diagnostics) and experience with 510(k) preparation and submissions to ensure compliance with FDA and other regulatory bodies. Responsibilities
Prepare and submit 510(k) applications for IVD products to facilitate timely market entry. Manage all aspects of regulatory submission processes, including documentation, timelines, and communication with regulatory agencies. Conduct regulatory risk assessments and develop mitigation strategies for IVD products. Stay updated with regulatory changes and ensure compliance of all IVD products. Liaise with R&D, Quality, and Manufacturing departments to gather necessary documentation for submissions. Provide regulatory guidance on product development from concept to commercialization. Review product labeling, promotional materials, and change controls for regulatory compliance. Assist in developing and updating regulatory strategies and inform stakeholders of regulatory developments. Base Pay Range $90,000-$150,000 per year.
Requirements
Bachelor's degree in Life Sciences, Biotechnology, Regulatory Affairs, or a related field. Minimum of 5 years of relevant industry experience, including at least 3 years in 510(k) preparations and submissions. Strong understanding of FDA regulations, guidance documents, and processes related to IVD products. Experience interacting with regulatory agencies, particularly the FDA. Excellent analytical, organizational, and communication skills. Detail-oriented with the ability to manage multiple projects simultaneously. Preferred Skills
RAC certification or similar. Benefits
Health Care Plan (Medical) 401K Paid Time Off and Sick Leave Training & Development We are an equal-opportunity employer committed to diversity and inclusion. We do not discriminate based on race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender identity or expression, age, disability, medical condition, pregnancy, genetic information, marital status, or military service. Seniority level
Mid-Senior level Employment type
Full-time Job function
Legal Industries
IT Services and IT Consulting
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CorDx is a multi-national biotech organization focused on innovation and supply in global health. With over 2,100 employees worldwide, serving millions in over 100 countries, CorDx provides rapid testing and point-of-care medical devices for detecting infectious diseases such as COVID-19, pregnancy, drugs of abuse, and biomarkers. The company is at the forefront of technology, artificial intelligence, and data science, aiming to deliver diagnostic solutions for critical healthcare questions. Job Description
We are seeking a highly motivated and experienced Regulatory Specialist to join our Regulatory Affairs team. The ideal candidate will have a strong background in IVD (In Vitro Diagnostics) and experience with 510(k) preparation and submissions to ensure compliance with FDA and other regulatory bodies. Responsibilities
Prepare and submit 510(k) applications for IVD products to facilitate timely market entry. Manage all aspects of regulatory submission processes, including documentation, timelines, and communication with regulatory agencies. Conduct regulatory risk assessments and develop mitigation strategies for IVD products. Stay updated with regulatory changes and ensure compliance of all IVD products. Liaise with R&D, Quality, and Manufacturing departments to gather necessary documentation for submissions. Provide regulatory guidance on product development from concept to commercialization. Review product labeling, promotional materials, and change controls for regulatory compliance. Assist in developing and updating regulatory strategies and inform stakeholders of regulatory developments. Base Pay Range $90,000-$150,000 per year.
Requirements
Bachelor's degree in Life Sciences, Biotechnology, Regulatory Affairs, or a related field. Minimum of 5 years of relevant industry experience, including at least 3 years in 510(k) preparations and submissions. Strong understanding of FDA regulations, guidance documents, and processes related to IVD products. Experience interacting with regulatory agencies, particularly the FDA. Excellent analytical, organizational, and communication skills. Detail-oriented with the ability to manage multiple projects simultaneously. Preferred Skills
RAC certification or similar. Benefits
Health Care Plan (Medical) 401K Paid Time Off and Sick Leave Training & Development We are an equal-opportunity employer committed to diversity and inclusion. We do not discriminate based on race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender identity or expression, age, disability, medical condition, pregnancy, genetic information, marital status, or military service. Seniority level
Mid-Senior level Employment type
Full-time Job function
Legal Industries
IT Services and IT Consulting
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