Common questions about fda 510(k) jobs careers in the medical device industry. Jobs are aggregated daily from multiple sources and filtered to this category.
- What does a 510(k) specialist do?
- A 510(k) specialist is responsible for preparing and submitting FDA 510(k) premarket notifications for medical devices. Key responsibilities include: Predicate device selection - identifying substantially equivalent devices, Submission preparation - compiling technical documentation, performance data, and labeling, FDA communication - responding to additional information requests, Classification analysis - determining appropriate device classifications. They work closely with engineering, quality, and clinical teams to ensure regulatory compliance.
- What qualifications are needed for FDA 510(k) jobs?
- Most 510(k) positions require: Education: Bachelor's degree in life sciences, biomedical engineering, or related field (Master's preferred for senior roles). Experience: 2-5 years for mid-level, 5-10+ years for senior positions. Skills: Strong technical writing, understanding of FDA regulations (21 CFR Part 807), knowledge of device classification, familiarity with eSTAR submission format. Certifications: RAC (Regulatory Affairs Certification) is highly valued but not always required.
- What is the salary range for 510(k) regulatory jobs?
- 510(k) regulatory salaries vary by experience and location: Entry-level (0-2 years): $65,000-$85,000, Mid-level (3-5 years): $85,000-$115,000, Senior (5-10 years): $115,000-$145,000, Director/Manager: $140,000-$180,000+. Major MedTech hubs like Boston, San Francisco, and Minneapolis typically offer 10-20% higher salaries. Remote positions are increasingly common.
