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Regulatory Affairs Specialist


  Hollis,   $110,000 - $130,000

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  Regulatory Affairs    Permanent

An established and highly experienced regulatory team are growing and looking for a someone who wants to learn and develop their software Medical Device Regulatory Affairs experience! Working on the full product life cycle, the organization have a software element to their medical device that has exciting applications in the oncology treatment space.

Responsibilities

  • Drive regulatory strategies for regional and local markets for their software medical device.
  • Coordinate activities related to regional and local regulatory submissions and approvals for software medical devices.
  • Stay abreast of local regulatory developments in the field (regulatory intelligence).
  • Review and approve marketing materials to ensure compliance with local advertising and promotional regulations

Experience Required

  • 3+ years of proven regulatory experience with medical devices in an ISO:13485 environment.
  • Experience with new product development standards and documentation for software products.
  • Experience in regulatory submissions and technical documentation for medical devices, software and services.

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.

Callum.Sparkes

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