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Details

Regulatory Affairs & Communications Specialist


Reference:KG-AHLY-788044 Location: Limerick
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed

The Regulatory Affairs Specialist - Regulatory Communications serves as a communication liaison between the manufacturer and the local affiliates or regulatory authorities and assists in assessing complaints for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS, PMCF, CER) and associated correspondence to applicable Regulatory bodies.

Reporting to: Senior Regulatory Affairs Specialist, you will:
• 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.
• Communicate with other internal Companies globally as necessary for reporting.
• Generate responses to inquiries on AE reports from various global regulatory authorities.
• Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests.

Qualifications
• 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.
• Knowledge of medical device quality standards/practises or similar regulated industry.
• Willingness and availability to travel on company business.


If you would like further Information you can contact the recruiter directly:

Kevin Silke | Tel: +353 (0) 1 507 9255