Senior Regulatory Affairs Manager

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 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.