Job Description
Our client, a Medtech company based in Cork, now seek a Regulatory Affairs Subject Matter Expert 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 be experienced in working with Product Development and Quality teams to support all regulatory activities within the company for both existing and new products.
Requirements for Regulatory Affairs SME:
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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