Regulatory Affairs Specialist at Waukesha, WI ** Full Time (Permanent) **
HI, Greetings from Oberon IT Inc !!! We have a Direct Client Requirement for you and the details are as follows Title: Regulatory Affairs Specialist Location: Waukesha, WI Duration: Full Time (Permanent) *Job Description:* Skills Experience Required:- · IRIS (International Regulatory Information Systems), medical device, device authorization matrix. · Identify and report any quality or compliance concerns and take immediate corrective action as required. *Job Responsibilities:-* • Main objective of this position is to Create Registration program records for US registered products in IRIS (International Regulatory Information Systems) which will take up of approximately 100% of the production time. • Under the scope of this objective candidate will perform the following activities. • Time allocated to these activities may vary depending upon the type of records and information identified. • Identification of the assigned and/or relevant medical device data values via existing 510(k) records – 20% • Compiling all the information pertaining to the medical device attributes for existing 510(k) legacy and NPI products • Completing and recording the UDI attributes for the each country record in IRIS from the information identified and collated from above activities • Collaborates with product engineering and marketing to establish Product Models pertaining to medical devices based on regulatory filings • Collaborates with product engineering and marketing to gather the relevant information required to complete the product model and its attributes and to associate this model information to US country records in IRIS -10% • Create the device authorization matrix for each assigned medical device • Attend workshops with different product teams and modalities, and help define/identify the product model and its impact to GTIN/ UDI attribution- 5% Best Regards, *Purushotham* Sr. Technical Recruiter | Oberon IT Inc 1404 W. Walnut Hill Lane | Suite: 102, Irving, TX 75038. Email: *purushot...@oberonit.com purushot...@oberonit.com* Direct: 972-330-5903 | Fax: 1-800-218-2820 www.oberonit.com -- You received this message because you are subscribed to the Google Groups SAP or Oracle Financials group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-or-oracle-financials+unsubscr...@googlegroups.com. To post to this group, send email to sap-or-oracle-financials@googlegroups.com. Visit this group at http://groups.google.com/group/sap-or-oracle-financials. For more options, visit https://groups.google.com/d/optout.
Regulatory affairs Specialist at Waukesha, WI ** Full Time (Permanent) **
HI, Greetings from Oberon IT Inc !!! We have a Direct Client Requirement for you and the details are as follows Title: Regulatory affairs Specialist Location: Waukesha, WI Duration: Full Time (Permanent) *Job Description:* Skills Experience Required:- · IRIS (International Regulatory Information Systems) , medical device, device authorization matrix. · Identify and report any quality or compliance concerns and take immediate corrective action as required. *Job Responsibilities:-* • Main objective of this position is to Create Registration program records for US registered products in IRIS (International Regulatory Information Systems) which will take up of approximately 100% of the production time. • Under the scope of this objective candidate will perform the following activities. • Time allocated to these activities may vary depending upon the type of records and information identified. • Identification of the assigned and/or relevant medical device data values via existing 510(k) records – 20% • Compiling all the information pertaining to the medical device attributes for existing 510(k) legacy and NPI products • Completing and recording the UDI attributes for the each country record in IRIS from the information identified and collated from above activities • Collaborates with product engineering and marketing to establish Product Models pertaining to medical devices based on regulatory filings • Collaborates with product engineering and marketing to gather the relevant information required to complete the product model and its attributes and to associate this model information to US country records in IRIS -10% • Create the device authorization matrix for each assigned medical device • Attend workshops with different product teams and modalities, and help define/identify the product model and its impact to GTIN/ UDI attribution- 5% Best Regards, *Purushotham* Sr. Technical Recruiter | Oberon IT Inc 1404 W. Walnut Hill Lane | Suite: 102, Irving, TX 75038. Email: *purushot...@oberonit.com purushot...@oberonit.com* Direct: 972-330-5903 | Fax: 1-800-218-2820 www.oberonit.com -- You received this message because you are subscribed to the Google Groups SAP or Oracle Financials group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-or-oracle-financials+unsubscr...@googlegroups.com. To post to this group, send email to sap-or-oracle-financials@googlegroups.com. Visit this group at http://groups.google.com/group/sap-or-oracle-financials. For more options, visit https://groups.google.com/d/optout.
