🚀 Hiring: Regulatory Affairs Specialist II
📍 Location: South Portland, ME, 04106(Onsite role)
💰 Pay Rate: $41/hr (W2)
⏳ Duration: 8+ Months Contract
🌟 About the Role:
We are looking for a detail-oriented Regulatory Affairs Specialist with strong expertise in IVDR and EU regulations. This role is ideal for professionals experienced in medical devices or IVD who enjoy working on global regulatory submissions and product approvals.
🔑 What You’ll Do:
Prepare & manage regulatory submissions and technical documentation
Ensure compliance with IVDR, EU, FDA & ISO regulations
Support product approvals, renewals, and amendments
Collaborate with cross-functional teams (R&D, Quality, etc.)
Maintain and organize regulatory records & documentation
✅ What We’re Looking For:
Bachelor’s degree in Biology, Chemistry, Engineering, or related field
4+ years of Regulatory Affairs experience
Strong knowledge of IVDR & EU regulatory requirements
Experience in medical device / IVD environment
Excellent communication & technical writing skills
Proficiency in MS Office (Word, Excel, PowerPoint, Visio)