REGULATORY AFFAIRS SPECIALIST
Our client a Galway based medical device start up company is recruiting an RA Specialist. The successful candidate will work on regulatory workload associated with clinical study on the Company’s CE-Marked device to be conducted under FDA approval in US and Germany. The job involves regulatory oversight of all the activities being undertaken in the Study across multiple vendors interfaced with companies own systems, including safety reporting and vigilance responsibilities. The job holder will also provide regulatory support to the international distribution and sale of the Company’s product(s).
Prepare FDA submissions to support US clinical activities, IDE supplements, IDE annual reports, Investigator Reports, and Pre-Subs.
Prepare technical submissions in accordance with current Medical Device Directive requirements, including Annual reports to Notified Bodies, Design Dossiers, Substantial Change Notifications and Clinical Evaluation reports.
Compile/review regulatory documentation to support IRB & Ethics Committee submissions in US and Europe.
Assist/prepare clinical reports from IDE, OUS and Post Approval Clinical Studies.
Prepare and manage international regulatory submissions in accordance with commercialisation plan.
Review and approve product labelling changes, promotional literature and marketing materials prepared by Company and its distributors.
Provide regulatory oversight of customer complaint handling procedure.
Provide input to regulatory aspects of change control, non-conforming process.
Participate as a Clinical Project team member to provide regulatory oversight of clinical operations including provision of safety reporting and vigilance support.
Provide a regulatory interface to clinical and commercial operations.
Assist with training in Quality System Regulation, ISO Standards and other International Regulations
Manage assigned aspects of the Quality System as required.
Life Sciences or Engineering Degree
Minimum 5 years’ experience as an RA Engineer/Specialist in medical devices, ideally in the cardiovascular field.
Clinical study experience is essential with experience of ensuring regulatory compliance across multiple vendors desirable.
Experience in all of the areas set out in the key responsibilities.
If you would like further Information you can contact the recruiter
James Cassidy | Tel: +353 (0) 1 5079250