Regulatory Affairs Manager - Freelance - Galway - Galway

Regulatory Affairs
Ref: 15 Date Posted: Friday 12 Jul 2019
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Regulatory Affairs Manager

Medical Devices

Freelance

Galway

 

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

 

Company;

Medical Device manufacturer – class III & combination device products

 

Location;

Galway – Southern Ireland

 

Position;

Freelance Regulatory Affairs Manager / Consultant

 

Rate;

To be discussed

 

Job reference:

J-0011

 

Our client is looking for someone who can hit the ground running in a position focused on managing global regulatory submissions including preparation of a PMA. In addition, this role will have responsibilities that include;

  • CE Marking / IDE Submissions
  • Technical File submissions
  • EU Substantial Change Notifications,
  • EU Clinical Evaluation Reports
  • Post market surveillance reporting
  • Compilation and review of regulatory documentations to support global pre & post market clinical study submissions
  • Review product labelling changes, change control and non-confirming process
  • Provision of regulatory oversight of clinical operations
  • Advise on regulatory strategy Implementing regulatory requirements in accordance of ISO 13485, MDD, MDR

 

Ideal applicatant;

Our client is looking for a freelance RA Manager with fully up to date medical device expertise who can hit the ground running – the ideal applicant will have a combination of the followsing skills / experience;

  • Previous experience of combination medical devices – highly sought after
  • Experience of class III medical device regulations – ideally
  • Experience within Vascular / Cardiovascular medical devices – highly advantageous
  • Experience of PMA submissions
  • Experience of FDA / 510(K) submissions
  • Experience of clinical evidence – background within research / scientific background – ideally
  • Up to date knowledge of MDD / MDR

 

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.