- Contribute to the regulatory strategy plans for new products, including required Regulatory Agency approvals.
- Provide regulatory input into labelling, test strategies for new product development, risk analysis, clinical, preclinical and marketing issues.
- Planning, preparation and submission of regulatory submission, including technical files and 510(k)s.
- Responsible for product registration in Europe, USA and other markets as appropriate.
- Manage and drive project tasks to ensure timely completion of regulatory requirements which apply to company projects.
- Manage all reportable events to the applicable Regulatory Agencies, follow-up any queries as required.
- Assist 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.
- Liaise and negotiate with the Notified Body and Competent Authority to ensure that planned actions for MDR implementation will satisfy the regulators expectations with respect to timelines.
- Prepares, maintains and organises the appropriate regulatory records to demonstrate compliance with the applicable standards and regulations.
- Bachelors’ degree in Science qualification in Microbiology, Toxicology, Biotechnology or equivalent.
- Established understanding of registration processes and their inter-dependencies as well as a demonstrable track record of driving regulatory strategic excellence.
- Ability to effectively communicate both verbally and in writing to all levels within the organization and parties external to the organization.
- Ideally have knowledge or requirements of European Medical Devices Regulations (EU-MDR), Regulations (EU) 2017/745.
- Knowledge of medical device quality standards/practises including ISO 13485 and harmonised standards applicable to sterile, implant devices.
- Ability to work off own initiative
- Proven problem-solving skills.
- High level of self-motivation.
- Excellent organisational skills and ability to prioritise
For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4320675 or email email@example.com