Senior Specialist, Regulatory Affairs

Senior Specialist, Regulatory Affairs

QIAGEN

Manchester, United Kingdom

Position Description

Key responsibilities of the position:

  • Prepare and submit required submissions to support Global regulatory submissions for QIAGEN’s range of IVD products
  • Ensure compliance to the EU In vitro Diagnostic Directive/Regulation, FDA, Health Canada and other global regulatory agencies for QIAGEN Products
  • In conjunction with the RA lead, participate in Companion Diagnostic development projects and generate and/or approve documents required for the project
  • Provide Life Cycle Management support to ensure that all changes that take place to QIAGEN’s products are in compliance with the appropriate regulatory requirements
  • Reviewing and approval of labelling, advertising and promotional materials in order to ensure regulatory compliance
  • Compilation and review of Technical Files

Position Requirements

  • A Bachelor’s degree (or equivalent) in science-related field
  • Experience in the medical device industry, preferably in vitro diagnostics in a similar role
  • Working knowledge of the MDD and IVDD, applicable ISO standards and US medical device/IVD regulation
  • Ability to handle multiple projects simultaneously

Personal Requirements

  • Flexible with the ability to adjust to changes in schedule, priorities
  • Able to travel when required by the business
  • Team work oriented
  • Must be articulate and able to communicate effectively with employees at all levels of the organization on the telephone and in person
  • Thrive in a fast-paced work environment, while possessing the ability to quickly change priorities and perform multiple tasks simultaneously
  • Demonstrated strong attention to detail; excellent time management skills and proven ability to meet tight deadlines and ability to work under pressure
  • Good verbal and written skills
  • Proficient with Windows-based software programs

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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