About this role
Director, Quality & Regulatory Affairs at Biolyst Scientific. Location: United States. Role: providing leadership, overseeing compliance, managing audits Requirements: Bachelor's in regulatory affairs/life sciences/pharmacy/engineering/quality management required; advanced degree preferred. 8–10 years QA/regulatory experience, 3–5 years leadership. Expertise with cGMP, FDA regs, ISO 13485/14971, CFR 820/210/211; inspections/audits experience; strong leadership and project management; English/Spanish preferred. Category: Research and Development (R&D) Seniority: Senior Level Commitment: Full Time Workplace: Onsite Languages: English, Spanish