Job Description
Our client, a Medtech company based in Cork, now seek a Regulatory Affairs Specialist who will be responsible for product registration in Europe, USA and other markets as appropriate.
The successful candidate will planning, preparation and submission of regulatory submission, including technical files and 510(k)s. This hire will contribute to the regulatory strategy plans for new products, including required Regulatory Agency approvals.
The ideal candidate will work the Design, Quality and Regulatory teams to support all regulatory functions within the company for both existing and new products.
Responsibilities for Regulatory Affairs Specialist:
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.
Provide regulatory input into labelling, test strategies for new product development, risk analysis, clinical, preclinical and marketing issues.
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.
Requirements for Regulatory Affairs Specialist:
Bachelors degree in Science qualification in Microbiology, Toxicology, Biotechnology or equivalent.
Proven experience with registration processes and their inter-dependencies.
Demonstrable track record of driving regulatory strategic excellence.
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.
Please contact Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. For a list of all our current vacancies, view our website http://www.rftgroup.ie/
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