RA Associate

RA Associate

Job Title: RA Associate
Contract Type: Contract
Location: South Glamorgan,
Salary: Negotiable
Start Date: 05/06/2017
Reference: RA-CW957
Contact Name: Catherine West
Contact Email:
Job Published: December 01, 2016 08:06

Job Description

Principal Duties and Responsibilities

  • Prepares and updates STED documents related to integration changes
  • Reviews source documents and provides regulatory inputs
  • Interacts with internal departments and projects, providing regulatory guidance
  • Interacts with international integration team and provides progress updates

Expected areas of Competence

  • Basic knowledge of medical device EU CE-marking and international regulations
  • Experience with medical quality system requirements according to ISO 13485
  • Ability to plan work in a systematic way by identifying and organizing all activities, including those of other functional areas, into time-dependent sequencing with realistic but aggressive timelines.
  • Preferable product experience in the field of orthopaedic products

Education/Experience requirements

  • University Degree in life sciences, technical (engineering) or related field
  • Good computer skills, including Microsoft Office Suite
  • Fluency in English both verbal and written

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