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

• 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-

Best Regards,


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


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