CorDx
Senior Regulatory Affairs Manager (Onsite)
CorDx - San Diego, California, United States, 92154
Work at CorDx
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Overview
Senior Regulatory Affairs Manager (Onsite)Senior Regulatory Affairs Manager (Onsite) 3 weeks ago Be among the first 25 applicants
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Who Is CorDx？
Find out more about this role by reading the information below, then apply to be considered.
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. 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: Senior Regulatory Affairs Manager
Location: Onsite - Atlanta, or San Diego
Position Summary:
The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and submissions. This individual will ensure compliance with all applicable regulations in the preparation of the submissions to FDA, provide regulatory guidance to cross-functional teams, and contribute to the successful approval and launch of innovative medical devices.
Key Responsibilities:
Prepare, review, and submit regulatory documents to FDA Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals Ensure that all products comply with applicable regulatory requirements, including FDA regulations and ISO standards Provide regulatory guidance to R&D team during product development life cycle. Stay updated on changes in regulatory requirements and communicate potential impacts to the organization Conduct regulatory assessments for product changes and provide recommendations for appropriate regulatory pathways Collaborate with internal stakeholders and external partners to ensure alignment on regulatory strategies and project timelines Represent the company in meetings with regulatory agencies and external partners as needed Ensure proper documentation and maintenance of regulatory submissions and correspondence with regulatory agencies
Requirements
Master's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field; advanced degree preferred Minimum of 7-10 years of experience in regulatory affairs within the medical device industry Proven track record of leading and successfully obtaining 510(k) and De Novo clearances/approvals Experience in interacting with FDA and other regulatory agencies
Skills & Competencies:
In-depth knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and other applicable medical device regulations Strong leadership and project management skills, with the ability to manage multiple projects and priorities Excellent communication, negotiation, and problem-solving skills Ability to work collaboratively in a cross-functional team environment Detail-oriented with strong organizational skills
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.Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionOther IndustriesIT Services and IT Consulting Referrals increase your chances of interviewing at CorDx by 2x Sign in to set job alerts for “Senior Manager Regulatory Affairs” roles.Regulatory Affairs Associate Director or Senior Manager San Diego Metropolitan Area $130,000.00-$200,000.00 2 days ago Associate Director, Regulatory Affairs CMCAssociate Director Regulatory Affairs CMCAssociate Director, Regulatory Affairs CMC San Diego County, CA $140,000.00-$170,000.00 3 weeks ago Associate Regulatory Affairs Manager (San Diego)Manager/ Sr. Manager, Regulatory AffairsManager, Vendor Contracts & Regulatory AffairsRegulatory Affairs Manager - Bilingual (Mandarin & English)EPMO Project Manager - Work in Regulatory andMedical Affairs domains We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Find out more about this role by reading the information below, then apply to be considered.
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. 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: Senior Regulatory Affairs Manager
Location: Onsite - Atlanta, or San Diego
Position Summary:
The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and submissions. This individual will ensure compliance with all applicable regulations in the preparation of the submissions to FDA, provide regulatory guidance to cross-functional teams, and contribute to the successful approval and launch of innovative medical devices.
Key Responsibilities:
Prepare, review, and submit regulatory documents to FDA Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals Ensure that all products comply with applicable regulatory requirements, including FDA regulations and ISO standards Provide regulatory guidance to R&D team during product development life cycle. Stay updated on changes in regulatory requirements and communicate potential impacts to the organization Conduct regulatory assessments for product changes and provide recommendations for appropriate regulatory pathways Collaborate with internal stakeholders and external partners to ensure alignment on regulatory strategies and project timelines Represent the company in meetings with regulatory agencies and external partners as needed Ensure proper documentation and maintenance of regulatory submissions and correspondence with regulatory agencies
Requirements
Master's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field; advanced degree preferred Minimum of 7-10 years of experience in regulatory affairs within the medical device industry Proven track record of leading and successfully obtaining 510(k) and De Novo clearances/approvals Experience in interacting with FDA and other regulatory agencies
Skills & Competencies:
In-depth knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and other applicable medical device regulations Strong leadership and project management skills, with the ability to manage multiple projects and priorities Excellent communication, negotiation, and problem-solving skills Ability to work collaboratively in a cross-functional team environment Detail-oriented with strong organizational skills
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.Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionOther IndustriesIT Services and IT Consulting Referrals increase your chances of interviewing at CorDx by 2x Sign in to set job alerts for “Senior Manager Regulatory Affairs” roles.Regulatory Affairs Associate Director or Senior Manager San Diego Metropolitan Area $130,000.00-$200,000.00 2 days ago Associate Director, Regulatory Affairs CMCAssociate Director Regulatory Affairs CMCAssociate Director, Regulatory Affairs CMC San Diego County, CA $140,000.00-$170,000.00 3 weeks ago Associate Regulatory Affairs Manager (San Diego)Manager/ Sr. Manager, Regulatory AffairsManager, Vendor Contracts & Regulatory AffairsRegulatory Affairs Manager - Bilingual (Mandarin & English)EPMO Project Manager - Work in Regulatory andMedical Affairs domains We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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