Our client develops innovative surgeon-driven trauma devices that are intuitive to use and improve patient outcomes while delivering value to the health care system. This is an organisation that continues to grow its footprint in Cork and as such, they require a Regulatory Affairs Specialist to join their team.
As Regulatory Affairs Specialist, you will collaborate with the Design, Quality and Regulatory teams to support all regulatory functions for both existing and new products. In addition, your responsibilities will be to;
- Contributing to the regulatory strategy plans for new products, including required Regulatory Agency approvals.
- Providing regulatory input into labelling, test strategies for new product development, risk analysis, clinical, preclinical and marketing issues.
- Planning, preparing and submitting regulatory submission, including technical files and 510(k)s.
- Responsible for product registration in Europe, USA and other markets as appropriate.
- Managing and driving project tasks to ensure timely completion of regulatory requirements which apply to company projects.
- Managing all reportable events to the applicable Regulatory Agencies, follow-up any queries as required.
- Assisting in the implementation of the transition strategy covering both existing and new devices in order to ensure compliance with EU MDR within the designated time frame.
- Liaising and negotiating with the Notified Body and Competent Authority to ensure that planned actions for MDR implementation will satisfy the regulators expectations with respect to timelines.
- Preparing, maintaining and organising the appropriate regulatory records to demonstrate compliance with the applicable standards and regulations.
You will have a minimum of 5 years' experience in a similar role in the Medical Device industry sector. A Bachelors degree in Science is required.
An excellent salary is on offer along with tangible career opportunities and the opportunity to work from home.
To discover more about this opportunity, apply now or contact Paul Wheatley at HRM on +353 21 4511190 for a confidential discussion.