Regulatory Affairs Associate

Job Title: Regulatory Affairs Associate Location: Alameda, CA Work Arrangement: 100% Onsite Duration: 12 Months Pay Range: $40 - $45 per hour (W2) Position Overview We are seeking a Regulatory Affairs Associate to support the Regulatory Affairs team by reviewing labeling, advertising, and promotional materials, ensuring regulatory compliance, supporting regulatory submissions, and collaborating with cross‑functional teams. This role also supports new product introductions (NPI) and post‑market regulatory activities. Key Responsibilities Review labeling, advertising, and promotional materials for regulatory compliance. Partner with Marketing to provide regulatory guidance and approval support. Support regulatory submissions, including 510(k), PMA, Health Canada, and Latin America submissions. Assist with NPI and post‑market regulatory activities. Develop and review Regulatory Affairs SOPs. Communicate regulatory requirements to cross‑functional teams. Prepare and maintain regulatory documentation. Required Qualifications Bachelor's degree or equivalent experience. Minimum 2 years of experience in a regulated industry (Medical Device, Pharmaceutical, Nutrition, or Food). Regulatory Affairs experience preferred; Quality, R&D, Scientific Affairs, or Operations experience will also be considered. Strong written and verbal communication skills. Excellent analytical, project management, and organizational skills. Strong attention to detail and ability to work collaboratively. Preferred Qualifications Bachelor's degree in a scientific, engineering, medical, or Regulatory Affairs discipline. 1+ year of Regulatory Affairs or Quality experience within the Medical Device industry. Experience reviewing labeling, advertising, or promotional materials. Knowledge of FDA regulations, Medical Device Quality Systems, Design Controls, and international regulatory requirements. RAC certification is a plus. Proficiency with Microsoft Word, Excel, PowerPoint, Visio, and SharePoint. We are looking for a candidate who is eligible to work with any employer without sponsorship. #J-18808-Ljbffr