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Regulatory Affairs Professional 3 (692665)
Last Updated: 2019-11-15
Employer: APN Software Services Inc.
Location: Newark, DE

Commercial Title: Regulatory Affairs Professional

Description:

Regulatory Affairs Specialist supports changes to commercial in vitro diagnostic reagents and consumables at company or prepare and submit product related regulatory submissions to international Regulatory Affairs team members. Responsibilities include:
· Assesses and documents regulatory impact of design and manufacturing process changes for…

Technical Writer/Editor 3 (692664)
Last Updated: 2019-11-15
Employer: APN Software Services Inc.
Location: Newark, DE

Commercial Title: Clinical Writer

Description:

Candidate will support Clinical Affairs IVDR efforts, including writing and reviewing clinical and scientific reports, performing literature searches, and summarizing the results of literature searches performed in clinical databases.

Qualifications:
- Bachelor’s degree in a scientific field with a minimum of 5-10 years’ experience; preferably…

Regulatory Affairs Professional 3 (692661)
Last Updated: 2019-11-15
Employer: APN Software Services Inc.
Location: Newark, DE

Commercial Title: Regulatory Affairs Professional

Description:

  • 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…

Legend

  • Registered Apprenticeship