Rose International INC Regulatory Affairs Professional 3 in Tarrytown, United States
Client Position Title: Regulatory Affairs Professional 3
Position Number: 338627
Location: Tarrytown, NY 10591
Position Type: Temporary
Required Skill Set:
Medical device, Microsoft Excel, Microsoft Word, Regulatory Affairs, SAP, Time Management, Windows 10
C2C is not available
Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.
Job Title: Regulatory Affairs Professional 3
Location: Tarrytown, NY, 10591
Duration: 12 Months
Schedule: 8AM-4PM or 9AM - 5PM
• Experience with and knowledge of (a) the European In Vitro Diagnostics Medical Devices Directive (IVDD 98/79/EC) and/or (b) the European In Vitro Diagnostic Regulation (IVDR 2017/746).
• SAP knowledge and hands-on experience.
• Experience with medical device labeling review.
• Regulatory Affairs experience with in vitro diagnostics.
• Proficiency with Windows 10 and Microsoft Office 365.
• Ability to work with cross-functional team to collect data for UDI and updating in SAP.
• Support the regulatory activities needed to comply with the European In Vitro Diagnostic Regulation (IVDR 2017/746) by performing the following:
• Gather regulatory and product information to support upload of this information to.
• SAP to support EU UDI.
• Identify and close gaps.
• Work collaboratively to complete tasks, both within regulatory affairs and with other departments.
• Create, review, and route for approval EU Declarations of Conformity.
• Provide periodic progress reports to supervisors.
• Attend in-person and teleconference meetings as assigned.
• Prepare finished IVDR technical documentation for submission to the Notified Body.
• Prepare quality records for electronic archival.
• Bachelor of Art/Science in a Science related field.
• Regulatory Affairs experience in an industry such as pharmaceuticals, medical devices, or in vitro diagnostics.
• Proficiency with Windows and Microsoft Office (especially Microsoft Word and Excel).
• Great time management and organizational skills.#CBRose#
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Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify).
(Posting required by OCGA 13/10-91.)