Regulatory Affairs & Labelling Specialist
Our client, a Irish owned organisation are currently recruiting for a Regulatory Affairs and Labelling Specialist to join their team. This is a permanent opportunity and the successful candidate will report directly into the Head of Quality and Regulatory Affairs.
·Execute and complete tasks and deliverables for CE marking activities as required to IVD directive
·Provide update and maintain status of product registration and notifications
·Provide documentation and certifications upon request
·Provide documentation and submit for product registration outside the European Union.
·Maintain a list and original (where necessary) of all current, relevant EU standards and Directives, 21 Code of Federal Regulation (CFR) and FDA Guidance Documents
·Read and understood the above listed standards
·Provide regulatory input and approval for changes and classification of changes to all documents impacting the QMS
·Assist in the preparation and maintenance of Technical Files for product registration and submissions to EU and International Competent Authorities and / or Regulatory Agencies
·Provide the required information to EU and International Competent Authorities for product registration and submission as required
·Input in to Post Market Surveillance and Risk Management processes.
·Responsible for approval and release of customer facing labelling such as, Instructions for use, XML files, Rilibäk Guidelines, Lot Confirmation Documentation, Kit & Vial Labelling
·Ensure that provided labelling is meeting relevant standards and regulations
·Provide support to Technopath Manufacturing QA, R&D Quality and Quality Systems areas from a quality perspective as required.
·Conduct internal quality system audits
·Minimum of degree qualification in a relevant Science, Engineering or Quality Assurance discipline
·4+ years industry experience working in a Quality Assurance regulated medical product environment
·Thorough knowledge of FDA 21CFR820, ISO13485, IVDD98/79/EC and international regulatory requirements
·Familiar with ISO 14971
·Strong interpersonal skills and the ability to communicate well
·Excellent attention to detail and ability to prioritise
If you would like further Information you can contact the recruiter directly:
Sinead Cullen | Tel: +353 (0) 1 507 9252