Regulatory Affairs Manager / Senior Regulatory Affairs Consultant – Freelance
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.
Apply today or contact Indo Professionals today for more information. Josh@indoprofessionals.co.uk / 0044 1256 597 800
Regulatory Affairs Consultant – Freelance
Office based in Galway with potentially 1-2 days from home
Market rates for a proven regulatory affair expert. Circa €600 - €1000 per day. Applicants seeking more or less may also be considered
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
- 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.