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Proofreader (JC151465346)
Last Updated: 2019-12-14
Employer: VIVA USA Inc
Location: Newark, DE

Req Ref No: MDDECP21
Location: Newark, DE
Duration: 10.0 months

Description

Description:

• Proofs technical documentation and labeling.
• Reviews updated documentation and labeling according to proofreading processes to ensure consistency and accuracy.
• Manages workload to meet committed dates and escalated workload concerns as needed.
• Escalates questions to…

IT Demand Management Professional (JC148817484)
Last Updated: 2019-12-14
Employer: VIVA USA Inc
Location: Newark, DE

Req Ref No: RPDEID1
Location: Newark, DE
Duration: 11.0 months

Description

description:

  • identifies business goals, objectives and needs of the business environment.
  • consults internal customers in the optimization and harmonization of business processes.
  • performs business process analysis in order to support business organization through it solutions.
  • contributes and supports planning…
Technical Writer/ Technical Editor (JC150834573)
Last Updated: 2019-12-14
Employer: VIVA USA Inc
Location: Newark, DE

Req Ref No: RKD22W-22
Location: Newark, DE
Duration: 12.0 months

Description

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…

Regulatory Affairs Specialist (JC150094898)
Last Updated: 2019-12-14
Employer: VIVA USA Inc
Location: Newark, DE

Req Ref No: RKDERA24
Location: Newark, DE
Duration: 12.0 months

Description

Description:

• Maintain technical files for in vitro diagnostic products in compliance with European In Vitro Diagnostics Directive 98/79/EC (IVDD) and IVDR
• Prepare and review technical file submissions for reagents, calibrators, controls and verifiers against relevant…

Regulatory Affairs Professional (JC150094872)
Last Updated: 2019-12-14
Employer: VIVA USA Inc
Location: Newark, DE

Req Ref No: RKDERA-33
Location: Newark, DE
Duration: 12.0 months

Description

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

Regulatory Affairs Specialist (JC150094874)
Last Updated: 2019-12-14
Employer: VIVA USA Inc
Location: Newark, DE

Req Ref No: RKDERA710
Location: Newark, DE
Duration: 9.5 months

Description

Description:

Regulatory Affairs Specialist supports changes to commercial in vitro diagnostic reagents and consumables at client’ or prepare and submit product related regulatory submissions to international Regulatory Affairs team members.

Responsibilities include:

· Assesses and documents regulatory impact of…

Procurement Engineer (JC151524770)
Last Updated: 2019-12-14
Employer: VIVA USA Inc
Location: Newark, DE

Req Ref No: MDDEPE-43
Location: Newark, DE
Duration: 10.0 months

Description

Description:

As part of the Manufacturing Execution and Test System (METS) group this position will support project managers and project engineers in the material procurement and status reporting of software-driven manufacturing testers that assess the production…

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