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Regulatory Affairs Officer 18 months long-term temp role

 

Regulatory Affairs Officer, Scientific Labs 18 months Long Term Temp Contract

Leamington Spa

Competitive Salary

Purpose: To provide support to the Regulatory Affairs Manager and Compliance Director with respect to establishing, implementing and maintaining processes needed for the validation of methods, and qualifications.

Responsibilities:

You will work closely with the Regulatory Affairs Manager managing the quality management system.


  • Assisting with the implementation and maintenance of the library of Regulatory Standards, Guidelines and Approved Codes Of Practice (ACOP)
  • Establishing, implementing and maintaining processes needed for the validation of methods, and qualifications, including reporting.
  • Promoting the awareness of regulatory and customer requirements throughout the organisation
  • Liaison with external parties on matters relating to the Regulatory requirements
  • Assisting with the compilation of technical files, validation/verification/qualification reports, and regulatory submissions

Key Outputs and Deliverables:


  • An up-to-date library of Regulatory Standards, Guidelines and Approved Codes Of Practice (ACOP)
  • Protocol and Report writing
  • Validation/verification & qualification schedule and maintenance
  • KPI Reporting

Key Stakeholder Relationships:


  • SLT
  • Laboratory Operations
  • Quality Assurance
  • Innovation and Technology Team

Skill and Capability Requirements:

Essential:

ü  Previous experience of working in the medical device field

ü  Experience with a range of standards and systems such as ISO 15189, ISO 15190, ISO 14001 and ISO 9001.

ü  Excellent communication and writing skills

ü  Scientific and Regulatory validation/qualification knowledge

ü  Strong statistical data analysis skills

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