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Job Information

Quality & Regulatory Affairs Manager

Information About this Role

Job Title: Quality & Regulatory Affairs Manager

Location: South of France

Industry: Medical Devices

Salary: Competitive salary and great benefits!

 

Overview:

  • Responsible for aligning the company’s business needs to regulatory and legislative change.
  • Manage and lead QA&RA staff.
  • Managing policy strategy and regulatory requirements.
  • Make sure regulatory compliance is achieved.

 

As a QA & RA Manager you will be responsible for:

  • Review and maintain the company quality management system ensuring quality documentation, processes and procedures and compliance to regulatory requirements.
  • Managing international product submissions.
  • Determine reportable events / incidents and advice the managing director accordingly.
  • 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.

 

To apply for the role of Quality & Regulatory Affairs Manager you will have

  • A proven track record / credentials in Regulatory Affairs management. (i.e. FDA, TGA) and ISO 13485.
  • Medical device QA & RA experience.
  • Must have experience of dealing with process validation, sterilisation, reprocessing surgical instruments.
  • Must have excellent I.T. skills to maintain various databases and present quality data in the form of departmental reports.
  • Previous Medical Device experience.
  • A valid driving licence.

 

If you are curious about this exciting opportunity as a Quality & Regulatory Affairs Manager APPLY NOW and change your life today.

 

For more information about the role call me Matthew for a confidential chat on 0203 8000 516 or email me on matthew@projectusconsulting.comtoday.

 

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

Projectus are the world leader in medical technology talent management.

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.