Regulatory Manager- IVD and 510(k)
CorDx
Regulatory Manager - IVD And 510(K)
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.
Vacancy posted 1 day ago
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