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)

We are seeking a “Regulatory Affairs Associate” to join one of our leading healthcare clients.

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.

• 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.

• 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 the candidate who are eligible to work with any employers without sponsorship.

If you’re interested, please click “Apply” button.