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 Job Title: Regulatory Manager - IVD and 510(K) 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. Requirements • Bachelor's degree in Life Sciences, Biotechnology, Regulatory Affairs, or a related field. • Minimum of 5 years of experience in relevant industry with min or 3 year 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