Regulatory Manager- IVD and 510(k)

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 body requirements.

Responsibilities

• Prepare and submit 510(k) applications for IVD products to ensure timely market entry
• Manage all aspects of regulatory submission processes, including documentation, timelines, and communication with regulatory bodies, as needed
• Conduct regulatory risk assessments and develop mitigation strategies for IVD products
• Stay updated with regulatory changes and ensure all IVD products comply with current regulations
• Liaise with internal departments (R&D, Quality, Manufacturing) to gather necessary documentation and data for regulatory submissions
• Provide regulatory guidance on product development projects to ensure compliance from concept to commercialization
• Review and provide input on product labeling, promotional materials, and change controls to ensure regulatory compliance
• Assist in the development and implementation of regulatory strategies and update stakeholders on regulatory developments affecting the company's products

Requirements

• Bachelor's degree in Life Sciences, Biotechnology, Regulatory Affairs, or a related field
• Minimum of 5 years of experience in relevant industry with minimum of 3 years' hands-on experience in 510(k) preparations and submissions
• Strong understanding of FDA regulations, guidance documents, and processes related to IVD products
• Experience in 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 Paid Sick Leave
• Training & Development

About the Role

CorDx is 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.