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Regulatory Affairs Officer

Regulatory Affairs Officer

Job Title: Regulatory Affairs Officer
Contract Type: Contract
Location: Dartford, Kent
Industry:
Salary: Negotiable
Reference: RAO101_1501148517
Contact Name: Alastair McCartney
Contact Email: a.mccartney@sciproglobal.com
Job Published: July 27, 2017 10:41

Job Description

Key Responsibilities:

  • Be the primary RA representative for the Immunodiagostics products for which Dartford has responsibility as well as RA responsibility for distribution activities of other MBD products that are distributed from the Dartford site
  • Develop and deploy global regulatory strategies and manage the pre-market submission of the Immunodiagostics products as well as assist with the registration of Dartford-distributed products as necessary
  • Act as the lead RA within a cross-functional project team, providing inputs into New Product Development, changes to existing products and other activities involving the complete life-cycle management of products
  • Be responsible for the planning and implementation of new and updated regulations as applicable to Dartford products while working in coordination with global regulatory affairs
  • Assist Line Manager in gathering relevant KPI and metrics
  • Lead change projects and site quality review meetings
  • Minimum Requirements/Qualifications:
  • Bachelors or Masters degree in Science preferably in the Biological Sciences or Regulatory Affairs
  • Proven experience in regulatory affairs in IVD or medical devices companies. Regulatory Affairs Certified individual preferred.
  • Ability to make balance decisions in relation to business/customer requirements and offer appropriate advice
  • Ability to work with minimal supervision with sound technical judgment and analytical skills in a highly matrixed business environment
  • Ability to coordinate and manage the completion of multiple projects simultaneously
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines
  • Strong organizational and follow-up skills, as well as attention to detail
  • Ability to travel within UK and internationally as required
  • Non-Negotiable Hiring Criteria:
  • Proven experience in RA in IVD or medical devices companies
  • Experienced in submission or Technical File compilation
  • Strong project management and organisational skills
  • Demonstrated experience in navigating complex pre-market submissions.
  • Experience working in a broader enterprise/cross-division business unit model preferred


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