Regulatory Manager- IVD and 510(k)

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.

Job Type : Full time Location : Onsite - San Diego Salary Range : $90000-$150000 / Yearly

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.