Job Title: Regulatory Affairs Specialist Location: Santa Clara, CA (100% Onsite) Duration: 12 Months (Contract) Pay Range: $41/hr – $46/hr (W2) Job Summary The Regulatory Affairs Specialist is responsible for managing regulatory submissions and government interactions related to products requiring regulatory approval. Key Responsibilities Author, prepare, and submit PMA supplements, including 30-Day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports. Serve as the primary point of contact with the FDA and other regulatory authorities. Ensure compliance with FDA PMA guidance documents and 21 CFR regulations. Provide regulatory strategy input and support cross-functional teams. Required Qualifications Bachelor’s degree required; advanced degree preferred. 5–8 years of direct Regulatory Affairs experience in medical devices. Recent experience with Class III implantable medical devices. Strong knowledge of FDA PMA processes and CFR regulations. We are looking for the candidate who are eligible to work with any employers without sponsorship. If you’re interested, please click “Apply” button