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Translation Internship

Oxford, UK

The Role

 

The Translation Intern liaises with the Regulatory Affairs and Quality teams, R&D and Product Management to provide regulatory input into NPI Project Core teams and APAC operations. They assist in the preparation and submission of regulatory applications and registrations as assigned including Design Dossier, Technical Files, 510(k)’s, CSDT files annual reports. They will assist in correspondence with review agencies, notified bodies, and trade associations on matters relating to product registrations and PMS. The Translation Intern will need to liaise with other departments serving as a Regulatory representative on all cross-functional teams across PD, guide and monitor regulatory compliance in the various countries.

The role will initially be for 6 months with the possibility of becoming a permanent member of the team.

Responsibilities

  • Primarily to translate documentation in preparation for regulatory submissions
  • Assist in market monitoring and regulatory research for new target jurisdictions.
  • Assist in maintaining compliance with relevant regulatory legislation and guidelines
  • Coordination of the regulatory activities associated with project team plans
  • Preparation, attendance and follow up of meetings with Regulatory Agencies
  • Coordinate the provision of information requested by regulatory authorities
  • General maintenance of Quality Management System
  • Interface with regulatory reviewers through written and oral communications as needed

Skills and Requirements: essential

  • Degree in a life science, law or appropriate engineering discipline
  • Fluency in spoken and written Japanese as well as ability to translate documents into English
  • Detail oriented and excellent written and verbal communication skills
  • Ability to work independently
  • Ability to plan and manage workload
  • Strong interpersonal skills and the ability to work as part of a team
  • Ability to support employees from other teams
  • Detail oriented and excellent written and verbal communication skills

Skills and Requirements: desirable

  • Degree in a STEM subject preferred

Interested in this position?

We are always looking for brilliant people to join us here at Perspectum Diagnostics.

Use the form below to send us your application.