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Regulatory Manager - 12 month contract

Employer
Achieva Group Ltd
Location
UK
Salary
Competitive
Closing date
27 Sep 2021

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Sector
Legal
Contract Type
Permanent
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We are currently searching for an experienced Regulatory Specialist to join my client on a 12 month contract basis. This role can start in November 2021 so the client is happy to consider someone who is currently working on a permanent basis and keen to transition into a contract role.

Responsibilities:

  • Performing Regulatory Assessments for planned Variations
  • Checking the current registered information (on file and in various systems)
  • Evaluating the Variation type and the required documents
  • Documenting and communicating the outcome of the evaluation
  • Preparation of Regulatory Submissions
  • Setting up the variation in various internal systems
  • Collecting the required documents, needed for submission
  • Screening of the Swissmedic Portal
  • Overseeing the status and milestones of the respective submission
  • Uploading and downloading of communication with the authority
  • Handling of Regulatory approvals
  • Downloading Approvals from the Swissmedic portal
  • Regulatory Information Systems
  • Keeping global regulatory information systems up to date
  • Product Information and Artwork (including Medical Devices)
  • Handling of approved product information (documentation, upload in relevant systems, incl. external websites)
  • Organization of translations (EN, FR, IT) of the product information
  • Requesting, reviewing, and approving artworks within the BART Artwork System
  • Providing relevant documents to quality for local product release
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@achieva.co.uk
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