Regulatory Project Manager
Quotient
Eysins, Switzerland
vor 1 Tg.

Job Description

Quotient is recruiting for a Regulatory Project Manager to join the Regulatory Affairs Team based in Eysins.

This role entails :

  • Lead and coordinate project to implement new or updated regulation within the organization, including the new IVDR.
  • Lead and coordinate regulatory processes projects.
  • Be the point of contact with our UK based operations for standardizing regulatory practices.
  • Support regulatory submission with International regulatory authorities.
  • Advise Quotient staff and project team members on data and information required for successful license applications and co-
  • ordinate work to ensure appropriate standards for submission.

  • Compile product information for the preparation of technical files and regulatory dossiers to support product license applications worldwide.
  • Liaise with regulatory authorities and external contract bodies and, in response to requests from these, to collate and interpret specialised information.
  • Provide regulatory support, guidance and training as needed to fellow team members.
  • Lead the design and implementation of regulatory processes and identify areas for potential improvement.
  • Lead and coordinate the regulatory watch process by maintaining knowledge of new or update regulatory requirements, guidance and industry standards.
  • Qualifications

  • Master degree or equivalent in life sciences and 5 years of experience in a Regulatory Affairs within the life science industry (medical device, IVD or drugs or biologics)
  • Prior experience in Project Management
  • Previous experience filing high class CE marking submission and / or other countries regulatory submission
  • Ability to interface with regulatory authority, analyse technical information and collect and interpret regulations, standards and guidance
  • Demonstrated ability to negotiate and convince
  • Ability to work in an international team in a fast-paced changing environment
  • Effective time management and prioritisation skills
  • Great attention to detail with a thorough and methodological approach to work
  • Excellent spoken and written English
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