What are the responsibilities and job description for the Regulatory Affairs Specialist position at HireTalent - Staffing & Recruiting Firm?
🚀 Hiring: Regulatory Affairs Specialist II
đź“Ť Location: South Portland, ME, 04106
đź’° 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)
Salary : $40 - $41