Regulatory Affairs Manager / Senior Regulatory Affairs Consultant – Freelance - Galway

€600-1000 per day - Regulatory Affairs
Ref: 15 Date Posted: Thursday 12 Sep 2019
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Regulatory Affairs Manager / Senior Regulatory Affairs Consultant – Freelance

Medical Devices

Galway

 

Our client is an established medical device company based in Galway. They are looking to hire the services of a Regulatory Affairs Manager / Senior RA Consultant on an interim basis.

 

They have developed a Class III implantable medical device and are further developing their product as a combination device / drug delivery product for UK and US markets.

 

Our client requires the services of an office based (with some flexibility) RA Manager / Senior Regulatory Consultant with solid experience of US FDA / 510(k) submissions.

 

Job reference:

J-00110

 

Apply today or contact Indo Professionals today for more information. Josh@indoprofessionals.co.uk / 0044 1256 597 800

 

Position:

Regulatory Affairs Consultant – Freelance

 

Location:

Office based in Galway with potentially 1-2 days from home

 

Rate:

Market rates for a proven regulatory affair expert. Circa €600 - €1000 per day. Applicants seeking more or less may also be considered

 

Job role:

This is a hands-on regulatory role responsible for management of US FDA / 510k regulatory submissions. Further responsibilities to include;

  • Clinical Evaluation Reports
  • Vigilance reporting
  • Post market surveillance reporting
  • Maintenance of existing CE mark, IDE and PMA files
  • Management and supervision of MDR
  • Provision of input of design control, change control and non conformance
  • Advice on regulatory strategies

 

Ideal applicant:

  • Degree level educated
  • Solid experience within medical device regulatory affairs
  • Ideally experience with Class III / implantable medical devices
  • Ideally experience of developing combination drug / medical device products
  • Cardiovascular medical device experience – advantageous
  • Solid understanding of regulatory strategy including timeline and budget management
  • Excellent communication, presentation and negotiation skills

 

 

 

Indo Professionals is a staffing specialist to the medical device industry. We focus on finding positions within regulatory, quality and clinical research. We work with our job seekers on a project basis, providing one to one consultation and up to the minute market information. Please contact the team today.