Regulatory Affairs Professional
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Newark, DE 19713
Req Ref No: RKDERA-33
Location: Newark, DE
Duration: 12.0 months
Analyzes the requirements and prepares product related regulatory submissions for IVDR.
Provide regulatory review of the claims and technical files to maintain EU CE marking
in compliance with European In Vitro Diagnostics Directive 98/79/EC (IVDD) and IVDR
Creates quality guidelines and work instructions relevant for maintaining regulatory compliance.
Investigate and close GAPs in documentation for technical files.
Troubleshoots and analyzes categorization, intended purpose and other IVDR topics
Initiates and escalates necessary activities if deviations are identified.
Ensures creation of adequate documentation for related audits/inspections.
5-8 years Deep professional know-how and experience in Regulatory affairs (preferably IVD products).
Solid professional judgment and problem solving competence. Improves existing processes and approaches.
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.