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Job Information

Head Of Regulatory Affairs

Information About this Role

Job Title: Head Of Regulatory Affairs 

Location: Paris, France

Industry: Medical Devices

Salary: Permanent with Competitive salary and great benefits!

 

Overview:

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

 

As an RA Manager you will be responsible for:

  • Review and maintain the company quality management system ensuring quality documentation, processes and procedures and compliance with regulatory requirements.
  • Managing international product submissions.
  • Determine reportable events/incidents and advice the managing director accordingly.
  • Manage CAPA system, ensuring the system is fully compliant with regulations and fully utilised to ensure product non-conformance is reduced and quality system is improved.

 

To apply for the role of Head of Regulatory Affairs you will have

  • A proven track record/credentials in Regulatory Affairs management. (i.e. FDA, TGA) and ISO 13485 or ISO 14971 and ISO 13408.
  • 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 UK driving licence.

 

If you are curious about this exciting opportunity as a Sales and Service Engineer APPLY NOW and change your life today.

For more information about the role call me Matthew for a confidential chat on chrome-extension://fgfcgceddeblecdcgjpckjfbnnpkjdad/images/logo.png0203 8000 507 or email me on simon@projectusconsulting.com today.

 

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

 

Projectus is 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.