Quality & Regulatory Affairs Manager

Posted 3 April by Premier Group Recruitment Easy Apply

JOB DESCRIPTION

Job Title: Quality & Regulatory Affairs Manager

Location: Near Chelmsford

Salary: £58k - £70k

My client is looking for a Quality and Regulatory Affairs Manager who has experience in the medical devices industry.

Job responsibilities
  • You will be responsible for aligning the company's business needs to regulatory and legislative change.
  • You will manage the Quality and Regulatory staff in maintaining the quality management system in accordance with the company strategy, policy and regulatory requirements.
  • You will be accountable for ensuring product and regulatory compliance is achieved in all products and supporting documentation.

Key Tasks

  • Ensure that all staff, including Office staff, Directors, Business Development Representatives, Distributors Suppliers and Sub-Contractors are fully aware of their regulatory responsibilities and ensure adherence to them on a continual basis
  • Review and assessment of the company Technical files and design dossiers
  • Manage international product submission and continual registration
  • Determine reportable events / incidents and advice the managing director accordingly. Manage any adverse incidents and communicate all relevant parties as necessary to bring incident to satisfactory conclusion
  • Manage audit schedule, conduct audits or write audit reports and close out CAPA actions where applicable.
  • Manage potential and existing suppliers/sub-contractors through performance monitoring system and QA audits to ensure desired quality and regulatory requirements are met
  • Define regulatory pathway for the new product, new international territories.
  • Manage CAPA system, ensuring system is fully compliant to regulations and fully utilised to ensure product non-conformance is reduced and quality system is improved
  • Proactively search out continual quality improvement for the company quality management system
Knowledge, Skills and Experience

Essential

  • Must have knowledge and proven track record / credentials in Regulatory Affairs management. (i.e. FDA, TGA) and ISO 13485.
  • Medical device Quality and Regulatory experience.
  • Must be experienced manager and leader, able to demonstrate excellent communication and interpersonal skills.
  • Must have experience of manufacturing.
  • Must have experience of dealing with process validation, sterilisation, reprocessing surgical instruments.
  • Capable of handling a diverse range of projects simultaneously.
  • Must have excellent I.T. skills to maintain various databases and present quality data in the form of departmental reports

Desirable

  • Degree qualified with an engineering, science or technology discipline
  • Able to effectively communicate to a variety of audiences in an appropriate, meaningful and influential manner

Premier are acting as an employment agency

Reference: 34497288

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