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Job Information

Quality Assurance & Regulatory Affairs Assistant

Information About this Role

Contract Duration: 12 month fixed term contract

Salary: Up to £30,000 dependent on experience.

Benefits:  Pension (6% Employer Contribution, 3% Employee Contribution), Life Assurance, 25 days holiday (+ Bank holidays).

Location: Bedfordshire area                                            

Department/Division: Medical Systems      

Overall Purpose: 

To support the Quality Assurance & Regulatory Affairs Manager in maintaining and improving the ISO 9001, ISO 13485, ISO 27001 and ISO 20000 management systems. To maintain compliance and certification to ISO 9001, ISO 3485, ISO 27001 and ISO 20000 and all other applicable regulatory compliance.                  

Key responsibilities             

  • Reporting to the Quality Assurance & Regulatory Affairs Manager 
  • Support process and procedure development and continual improvement activities
  • Carry out Internal Audits in a timely manner
  • Maintain training records and support all training and induction activities
  • Assist and support with external and third party audits
  • Deputise for the Quality Assurance and Regulatory Affairs Managers as required
  • Assist in the preparation of tender documentation
  • Management and maintenance of the Document and Record Control processes
  • Support the Corrective and Preventive Action (CAPA) process
  • Support the management of Customer Complaints
  • Support Supplier approval and management activities

Key competencies

  • The ability to engage effectively with employees at all levels and other internal and external stakeholders
  • Professional and courteous management of issues and complaints
  • Good knowledge of root cause and problem solving methodologies
  • Flexible and adaptable

Requirements:

  • Experience of Quality assurance & regulatory affairs within the medical device sector
  • Experience of ISO 9001 and/or ISO 13485 preferred
  • Internal auditing experience preferred
  • Ability to write clear and concise documentation e.g. procedures, audit reports etc.
  • Good interpersonal and communication skills (both written and oral)

Apply now and change your life today! 

For more info about the role contact me Catherine, at catherine@projectusconsulting.com today 0203 8000 512 

Due to a high number of applicants only successful candidates will be contacted. A consultant will reach you within 7 working days.

Our sole mission is to connect medical technology companies with the best industry professionals across the globe. We place people across the full medical device spectrum including R&D, Regulatory, Engineering, Sales, Marketing, Clinical and Service.

For all our services visit www.projectusconsulting.com and discover more ways that we can help you.

Deadline for applications: Friday 25th January.