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Details

Regulatory Affairs Specialist


Reference:JCABDY-868112 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Our client a medical device early stage company wishes to add a Regulatory Affairs Specialist to our team. The successful candidate will work with the Design, Quality and Regulatory teams to support all regulatory functions for both existing and new products.

Role/Responsibilities

• 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.

Skills/Experience

• 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



James Cassidy | Tel: +353 (0) 1 5079250