Regulatory Resource for 6+Months Contract Role in Batesville, IN or Milwaukee - (Batesville, IN)

Position title: Regulatory Resource for 6+Months Contract Role in Batesville, IN or Milwaukee, WI ; Position classification:Contract ; Job Location:Batesville, IN ; Job Skills: N/A ; Position summary: Position details: · Job role is Onsite Regulatory Lead as a technical liaison between customer and offshore team · Background in Medical Domain background – Medical Devices & Disposables · Understanding of Medical regulatory standards is mandatory (EU Regulations – MDD & MDR) · Background in Remediation of QMS, Tech File, DHF and Risk Management File · Understanding of Medical Device - Product development and Sustenance Processes · Strong in written and oral communication abilities · Awareness of regulatory qualifications like UL / IEC 60601, ISO 13485, ISO 14971 · Review MDR Gap analysis, Tech file Gap analysis, Support in Remediation Plan preparation & review · Address Regulatory / Standards related queries from customer then and there