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Job Reference: RV/HQ1253

Regulatory Affairs Specialist

  • Essex, Essex, England
  • Permanent / Full Time
  • Life Sciences Team
  • £30000 - £35000

The Quality & Regulatory Specialist with the Quality & Regulatory Manager ensures the company readiness in compliance with standards and certifications.

  • Assist in performing Post Market Surveillance.
  • Member of internal auditor team
  • interact with all areas of the business in order to process/co-ordinate:
  • customer complaint investigations,
  • identify incidents of non-conformance
  • support the company continual improvement and CAPA programme.
  • approve and implement validation documentation
  • product CE marking and US submissions

The job holder is an integral member of the quality team in achieving the quality objectives and initiatives for continuous improvement.

Responsibilities & Duties:

  • Support the Quality & Regulatory manager in the general maintenance of BQMS, regularly update the quality system performance and reporting data
  • Create, review and update relevant SOPs and Work Instructions needed to support/improve BQMS, Including ownership of the document and data control process
  • Facilitator of Corrective Actions and provide performance report on periodic basis.
  • Provide support with CAPA, complaint and product investigation as needed
  • Provide training including generating training materials to attain necessary competence of personnel and/or increase their awareness of BQMS requirements
  • Maintain membership & subscriptions (e.g. BSI)
  • Lead / support regulatory and customer audits ensuring timely closure to open actions Advice / support on regulatory matters as required
  • To process customer complaints in accordance with company policy and procedure, assigning investigation/action to appropriate personnel and where necessary perform the investigation of the complaint.
  • To review the outcome of the investigation for suitability and adequacy regarding resolution of the complaint and determining further investigation/follow-up where deemed appropriate.
  • Ensure any samples received regarding the complaint are properly handled and stored.
  • Identification of archive sample storage to allow timely sample retrieval in accordance with company procedure.
  • Perform PMS activities to MDR requirements
  • Review and approve CE mark and FDA submissions
  • Develop and implement validation documents in an ISO controlled environment

Knowledge & Experience:

  • 3+ years’ experience in manufacturing environment or equivalent certification
  • Knowledge of international/harmonized standards, such as, ISO 9001/ISO 13485
  • Knowledge of QA principles and system concept
  • Experience in process control improvement projects
  • Experience in Validation protocols and reporting
  • 2+ years’ experience of CE Marking process and FDA submissions

Behaviours & Skills:

  • Outstanding written and oral communication
  • Excellent organizational skills with large volumes of data, documents / records
  • Excellent interpersonal and influencing skills

Key Performance Indicators:

  • Production of quality documents in efficient manner
  • Resolution of NCR issue in reasonable time as defined/agreed
  • Effective records and traceability management

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