New Regulatory Affairs Job in Tarrytown, NY!
Position Title: Regulatory Affairs

Position Number: 341229

Location: Tarrytown, NY 10591

Position Type: Long Term Contract

Required Skill Set:

Medical device, MS Excel, Regulatory Affairs, SAP

Position Description:

**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
Location: Tarrytwon, NY 10591
Duration: 12+ Months
Schedule: Shift 1; M-F (8:00 AM - 5:00 PM)

• Work location is Tarrytwon, NY. Due to the pandemic, the position will initially be remote until we can return to the office.
• Manager looking for 2-5 years experience

• Support the regulatory activities needed to comply with the European In Vitro Diagnostic Regulation (IVDR 2017/746) by performing the following:
• Create and review technical documentation for reagents, calibrators, controls, and other in vitro diagnostic products to comply with European In Vitro Diagnostic Regulation (2017/746/EU).
• Gather regulatory documents and information to support creation of technical documentation.
• Identify and close gaps in technical documentation.
• 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.

Must Have
• Education: 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.

• 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).
• Experience with SAP.
• Experience with medical device labeling review.
• Regulatory Affairs experience with in vitro diagnostics.
• Proficiency with Windows 10 and Microsoft Office 365.

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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.)
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