Eden Prairie, MN30+ days ago
Assist in Regulatory Inspections (FDA, MDSAP, etc.) Participate in CAPA investigation and action plan development that may result from Regulatory Inspections, Third-Party Audits and Internal Audits Assist with Global product recall activities Other duties as assigned Qualifications (Knowledge, Skills & Abilities): Minimum BA or BS degree or a combination of education and experience providing equivalent knowledge 2+ years Complaint Handling experience in the medical device or a regulated industry Working knowledge and experience with ISO 13485, 21CFR 820 Familiarity with 21 CFR 803 Medical Device Reporting and ISO 14971 Risk Management. Ability toread, analyze and interpret regulatory communications and complaint data Must have strong verbal and written communication skills, initiative, flexibility, creative thinking and the ability to understand the underlying technical principles of ACIST products Must also have the ability to work with individuals in a congenial and cooperative manner Experience working on cross-functional teams Ability to develop clear, concise, and timely oral and written reports.