Regulatory Affairs Associate

Regulatory Affairs Associate

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.

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.