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Siemens Jobs Edinburgh – Regulatory Affairs and Quality Specialist

Siemens

Job Description:

We have 2 roles available, 1 based in Ireland and 1 in the UK. This is a homebased position.

Job Responsibilities:

  • Contribute to process improvements while ensuring regulatory compliance
  • You will be working within the European Authorised Representative team supporting the EU Authorised Representative Manager.
  • You will also work closely with other departments providing regulatory / quality support and guidance.
  • You will work closely with the team to ensure compliance with the following standards:
    • RoHS Directive 2011/65/EU
    • Medical Device Regulation 2002 (SI 2002 No 618)
    • IVD Directive 98/79/EC
    • IVD Regulation 2017/746

Job Requirements:

Qualification & Experience:

  • Must be able to work independently when required ensuring compliance to local and global procedures / processes
  • Self-motivated with the ability to deliver a high standard of work within agreed deadlines. Good time management and facilitation skills.
  • Must work efficiently and be self-disciplined. Able to work well under pressure and to be able to identify the need to prioritise when required.
  • Good IT skills, specifically Microsoft Office (including Outlook, Excel, Word, SharePoint etc)
  • Must be understanding, where necessary, recognise and respect views from others.
  • Promotes excellence and embraces right first time culture. A strong understanding of the need for accuracy.
  • Significant professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.
  • A formal qualification, degree level or equivalent, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices;
  • Excellent interpersonal and organisational skills. Must be able to work well within a team and display strong problem solving skills
  • Strong communication skills – must be a confident and organised communicator (verbal and written).

Job Details:

Company: Siemens

Vacancy Type:  Full Time

Job Location: Edinburgh, GB

Application Deadline: N/A

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