Regulatory Affairs Specialist - ALOIS Solutions : Job Details

🚨 Now Hiring: Regulatory Affairs Specialist (Medical Device)

📍 Location: Irvine, CA (Hybrid: Start Onsite, Then Transition to Hybrid)

🕘 Schedule: Full-Time | Monday–Friday | 8 hrs/day

💼 Industry: Medical Device Manufacturing

🔍 About the Role

We're looking for a highly organized and detail-oriented Regulatory Affairs Specialist to support a global medical device regulatory project. You'll work with cross-regional teams across Asia, Mexico, Korea, and Taiwan, so flexibility for late afternoon calls is expected. This is a unique opportunity to work on a high-impact document transfer initiative involving over 6,000 regulatory files.

🧩 Key Responsibilities

• Collaborate with global teams to manage regulatory documentation and licensing transfers
• Dig into Windchill to extract reports, protocols, and supporting data
• Prepare, review, and update regulatory submission materials
• Translate complex technical data into regulatory-friendly content
• Ensure alignment with FDA and international regulations
• Support submission strategies for moderate-complexity products
• Maintain detailed documentation and ensure regulatory compliance

📌 Ideal Candidate Will Have:

• Bachelor's Degree in Engineering (required)
• 1–2 years of regulatory experience, preferably in medical devices
• Experience working with document control systems like Windchill
• Strong attention to detail and organizational skills
• Excellent communication skills to coordinate across global time zones
• Previous experience with BD or other major med device companies is a strong plus

🌎 Why This Role Stands Out:

• Support a critical global project with high visibility
• Collaborate with international teams on cutting-edge med device products
• Build experience in regulatory operations and cross-border compliance
• Hybrid flexibility after initial onsite training period

📩 Ready to take the next step in your regulatory career?

Apply today or DM us to learn more!