Regulatory Communication Specialist Position

2 days ago

Limerick, Limerick, Ireland beBeeRegulatory Full time €60,000 - €80,000
Regulatory Communications Expert

We seek a Regulatory Communications Specialist to serve as a communication liaison between our manufacturer and regulatory authorities.

This role involves assessing complaints for Regulatory Reporting, including Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS), field action and related correspondence to applicable Regulatory bodies.

The ideal candidate will have a thorough knowledge of EU & US medical device regulatory requirements.

Key Responsibilities
  • Assess complaints from customer support and delivery centres for adequate information to determine if events meet Regulatory Reporting requirements.
  • Utilize complaint software systems for processing complaints.
  • Generate appropriate regulatory reports based on assessment.
  • Liaise effectively with regulators on all issues with regard to regulatory reporting.
  • Ensure that confirmed reportable events are escalated to the appropriate personnel in a timely manner.
  • Communicate with other global companies 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.
Requirements
  • Third-level qualification in Science/Engineering desired.
  • Experience in a regulated industry in a similar role required.
  • Thorough knowledge of EU & US medical device regulatory requirements.
  • Knowledge of medical device quality standards/practises or similar regulated industry.
  • Good communication and inter-personal skills.
  • Proven problem-solving skills.
  • Good computer skills including knowledge of Microsoft Office.
  • Proven organisational skills.
Additional Information
  • Mid-Senior level position.
  • Contract employment type.
  • Marketing, Public Relations, and Writing/Editing job function.
  • Medical Equipment Manufacturing industry.

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