An opportunity has arisen within a leading Limerick based medical device company for a Regulatory Affairs Specialist. The successful candidate will act as a communication liaison between the company and the local affiliates or regulatory authorities and assists in assessing complaints for Regulatory Reporting.
Assess complaints from global distribution centres for adequate information to determine if event meets Regulatory Reporting requirements.
Utilize appropriate complaint software systems for processing complaints to/from distribution centres and QE Investigation functions.
Generate appropriate regulatory reports based on assessment.
Liaise effectively with regulators on all issues with regard to regulatory reporting.
Ensuring that confirmed reportable events are escalated to the appropriate personnel in a timely manner.
Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests.
Assist in coordination of Recall / Field Action administration activities between manufacturer and distribution centre.
Reviewing and approving reports and responses as necessary.
Input and adherence to the scheduling and management of Post Market Surveillance (PMS) plans and reports, Post Market Clinical Follow Up (PMCF) plans and reports and clinical evaluations (CEPs, CERs). Maintains appropriate regulatory records to demonstrate compliance with applicable regulations.
Responsibility for implementing applicable regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required.
Qualifications and Experience:
Third level Qualification in Science/Engineering desired.
A number of years experience in a regulated industry in a similar role required.
Thorough knowledge of the EU & US medical device regulatory requirements.
Knowledge of regulatory requirements in MDSAP countries.
Desirable to have knowledge of requirements in other jurisdictions
Good communication and inter-personal skills.
Proven problem-solving skills.