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Regulatory Affairs Professional 3

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Job Details
Job Order Number
Company Name
APN Software Services Inc.
Physical Address
Glasgow Business Community
Newark, DE 19702
Job Description

Commercial Title: Regulatory Affairs Professional


  • 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.

As a VEVRAA Federal Contractor, APN Software is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. APN complies with applicable state and local laws governing nondiscrimination in employment.

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