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
