Regulatory Affairs Specialist

Kelly Services • Alpharetta, GA

391d • $49,920 - $49,920

About The Position

The Regulatory Affairs Specialist I position at Kelly Services involves supporting regulatory compliance in the medical device industry. This remote contract role focuses on assisting with new product development, ensuring compliance with FDA and international regulations, and fostering a collaborative work environment that values professional growth.

Requirements

• Bachelor's degree in biological sciences, microbiology, chemistry, or engineering; Graduate studies in Regulatory Affairs are preferred.
• 3+ years of experience in Regulatory Affairs, preferably in a medical device company, with experience communicating with regulatory agencies.
• Working knowledge of ISO and applicable international regulations, compliance, and audit practices.

Responsibilities

• Assisting the contracts and sales team during new product development and design control processes.
• Reviewing labeling and Copy & Claims requests for compliance with internal procedures and FDA requirements.
• Coordinating activities necessary to ensure global regulatory compliance with FDA, Canadian, European, and other agency regulations.

Benefits

• Medical/Dental/Vision/Life Insurance
• 8 Paid Holidays
• 3 weeks of PTO
• 401K
• Weekly pay

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree