What are the responsibilities and job description for the Regulatory Affairs Specialist position at Soho Square Solutions?
🚨 Hiring: Regulatory Affairs Coordinator III | Medical Devices | Hybrid
We are looking for an experienced Regulatory Affairs professional with strong expertise in FDA and EU MDR regulations to support Class II and Class III medical devices across the product lifecycle.
🔹 Role: Regulatory Affairs Coordinator III
🔹 Work Model: Hybrid (4 days In-Office)
🔹 Experience: 5–7 Years
🔹 Location: Irvine, CA
✅ What You’ll Do:
• Support U.S. Class II and EU Class II/III regulatory activities
• Prepare and maintain regulatory submissions and technical documentation
• Ensure compliance with FDA and EU MDR requirements
• Collaborate with cross-functional teams on product lifecycle activities
• Maintain EU MDR technical files and regulatory documentation
✅ What We’re Looking For:
• Strong medical device regulatory experience
• Hands-on experience with EU MDR technical documentation
• Knowledge of FDA submissions and global regulations
• Excellent analytical, communication, and organizational skills
• Ability to manage multiple priorities in a fast-paced environment
🎓 Education:
Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related field
📩 Interested candidates or referrals are welcome.
Please send your resume or connect directly via LinkedIn.
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