Senior Regulatory Affairs Specialist

Fremont  ‐ Onsite
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Keywords

Description

Position Summary:

The Regulatory Affairs representative will be involved with EU regulatory activities within CDD Fremont, particularly in regards to Technical File creation and updates.

Key Responsibilities:
  • Prepares documents necessary for new and continuous product market access in the EU, including technical file creation and updates for CE marking.
  • Supports registration of products in the EU.
  • Interacts with R&D and other cross functional departments to obtain documents needed for preparation of regulatory files.
  • Helps with the design and implementation of a new template for technical file creation.
  • Helps train and coordinate CE mark activities of more junior regulatory staff.
  • Provides input for regulatory requirements pertaining to the IVDD and current EU regulations and publications.

Minimum Requirements/Qualifications:
  • Bachelor's Degree in a scientific discipline
  • Minimum 5-8 years direct experience in regulatory affairs with extensive experience with technical files and CE marking.
  • Experience in making regulatory assessments with strong knowledge and understanding of in vitro diagnostics regulations, particularly the IVDD and international standards.
  • Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.
  • Excellent verbal communication skills.


Non-Negotiable Hiring Criteria:
  • Experience in the preparation of EU technical files.
  • Strong knowledge of the IVDD.


To find out more about Real please visit www.realstaffing.com
Start date
04/2014
Duration
9-12 Months
From
Real Staffing
Published at
28.03.2014
Project ID:
685957
Contract type
Freelance
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