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Job Reference: HH/HQ1385

Regulatory Affairs Manager

  • Blackburn, Lancashire, England
  • Permanent / Full Time
  • Life Sciences Team
  • £50000 - £55000

Regulatory Affairs Manager

Location: Blackburn with some elements of working from home

Salary: £50-55k

 

Purpose of the role

Reporting to the Director Global QA&RA, to help build and sustain QA&RA systems and processes, by:

  • Ownership and administration of all aspects of Regulatory Affairs.
  • Management of ISO 13485 Compliance, Development, Implementation and Training of all related and supporting processes.
  • Auditing all aspects of ISO 13485 and ISO 15378 within the organization and associated supply chain partners where appropriate.
  • Ownership of External Regulatory Affairs Audit Program.
  • Maintenance of Drug Master Files (DMF), Annual reports and updates as appropriate in addition to all Product Approvals and CE Declarations.
  • To maintain an independent perspective on Product Approval and Manufacturing Production Processes and Product Performance
  • To ensure the monitoring and reporting of Product Performance and Post Sales Management
  • Regulatory management of customer complaints and Corrective and Preventive Action Management
  • Forward looking for (external) changes to regulatory landscape and participation in relevant working groups

Responsibilities and tasks

  • Delivery of the Regulatory Affairs requirements
  • Management and completion of all Regulatory Submissions.
  • Auditing of all related processes.
  • Training and education of staff in the field of GMP, GCLP, Regulatory Affairs and CAPA.
  • Management of all Regulatory Affairs documents such that requested or required documents are available easily. KPI’s to be determined
  • Supporting Development activities to ensure early implementation of the legal requirements.
  • Representation to the company and its agencies at public events and institutions
  • Ensure all Regulatory Reporting requirements are met.
  • Collaboration with co-workers regarding Regulatory Affairs ensure efficiency with other business areas to minimize duplication of effort

Critical success factors

  • Ensure the legal right to supply products to regulated markets is achieved and maintained.
  • Ensure the success of Regulatory Audits.
  • Ensure the success of Customer Audits with regards to Regulatory Affairs.
  • Ensure the completion of all Regulatory Documents, on time in full achieving 100% right First Time.
  • Ability to build relationships and collaboration partnerships with remote teams.

Required expertise

  • Knowledge of EU/2017/485, 90/385/EEC, 93/42/EEC, 89/79/EC.
  • Knowledge of ISO 13485 and ISO 15378.
  • Knowledge of UK Legislation and UKCA Marking Requirements.
  • Knowledge of Business management, Change Management and Improvement Methodologies.

Experience

Education

  • Degree and/or Postgraduate Qualification in a related subject
  • Relevant training in Regulatory Affairs
  • Knowledge and previous experience in a similar role

Projects

  • Involvement in development projects as a Consultant regarding what should be tested and documented for each product

Leadership

  • Confident in subject matter, able to demonstrate expertise
  • Ability and profile to influence externally with Regulators and Notified Bodies, and Customers

Intercultural competence

  • Awareness of cultural differences
  • Ability to work efficiently with other cultures.
  • Languages spoken and written – English (Required)
  • Additional Languages of Spanish and German would be an advantage.

If you’re interested, please click apply now. For more information, please contact Harvey in the Life Sciences team.

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