RA Officer
Leica Biosystems
Newcastle, Tyne
38d ago

Position Summary and Overview of RA Officer role

This is a professional position with responsibilities for supporting tasks associated with the site regulatory obligations.

Will follow existing policies, procedures and work instructions to plan and conduct tasks. Will receive instruction and guidance from manager(s) or Sr.

RA Officer / Specialist(s). The entry level RA Officer / Specialist will minimally have a college or university degree in science (or equivalent), and the ability perform routine tasks.

With additional experience, the RA Officer / Specialist will work more independently and expected to apply experience to more complex tasks and problems.

Major Responsibilities

  • Conduct tasks that support one or more areas of the site regulatory responsibilities. May include tasks in the following areas :
  • Adverse events and patient safety (MDR, Vigilance, clinical trials)
  • o Support the review and analysis of product complaints, clinical reports and other data against established processes and procedures.

    o Support and organize safety and filing decisions for in collaboration with Sr. RA Officer(s), RA management.

  • Compliance
  • o Support and organize the review and approval of labeling, advertising and promotion for compliance to applicable regulations

    o Support Sr. RA Officer(s), RA management in the implementation of new regulations.

  • Submissions, registrations, device listings, site licenses
  • o Work with global colleagues in support of product registrations and submissions.

    o Establish and maintain official site regulatory files according to government expectations and company procedures

    o Serve as site RA representative on new product development teams and change management initiatives

    o Establish and maintain device listings and licenses according to government requirements

    o Support the documentation of regulatory strategies

  • Utilize knowledge and experience to identify and solve problems within the regulatory area.
  • Use Danaher Business System (DBS) tools on a regular basis to continually improve the RA function.
  • Serve as a resource to support senior staff including Senior RA Officer / Specialist(s).
  • Establish and maintain strong relationships with RA colleagues and wider QRA team.
  • Maintain working knowledge of relevant regulations and requirements that affect the business.
  • Other duties as assigned by management.
  • Qualifications

    Required Skills / Experience / Education

  • Bachelor’s degree in science, medical or technical field and experience in medical device Regulatory Affairs
  • Graduate or advanced degree preferred
  • Experience in the IVD field preferred experience very beneficial
  • Must have requisite training or certification in medical device Regulatory Affairs through on-the-job training, seminars, training.
  • Relevant certifications preferred.

  • Depending on assigned area :
  • o Experience with regulatory submissions and registrations

    o Experience with regulatory affairs

    o Experience with regulatory compliance

    Competencies

  • Ability to apply practical RA experience and knowledge to one or more area(s) of regulatory affairs
  • Ability to identify and assess patient and user risk
  • Ability to work independently
  • Strong organizational skills. Ability to multitask
  • Strong communication skills. Ability to explain difficult or sensitive information. Works to build consensus.
  • Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, reports.
  • High level of integrity
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