About this role
Regulatory Affairs Specialist at Solesis. Location: Winston-Salem, North Carolina, United States. Role: Prepare submissions, Maintain registrations, Monitor regulations Requirements: Bachelor’s degree in life science or engineering; 3–5 years in regulatory affairs for medical devices; knowledge of US FDA regs and EU MDR; RAC preferred. Category: Research and Development (R&D) Seniority: Mid Level Tools: FDA regulations (21 CFR Part 820, 803, 806, 807), EU MDR 2017/745, ISO 13485, CE Marking Certifications: regulatory affairs (rac) Commitment: Full Time Workplace: Onsite Languages: English