Effective Regulatory Liaison

2 weeks ago

Limerick, Limerick, Ireland beBeeRegulatory Full time €60,000 - €80,000
Regulatory Communications Specialist Job Overview

The Regulatory Communications Specialist acts as a communication bridge between manufacturers and regulatory authorities. Their role involves assessing complaints to determine if they meet regulatory reporting requirements, generating reports, and maintaining effective liaison with regulators.

Key Responsibilities:
  • Assess customer support and delivery centre complaints for adequate information.
  • Utilise complaint software systems for processing complaints.
  • Generate appropriate regulatory reports based on assessment results.
  • Establish and maintain strong relationships with regulators on all issues related to regulatory reporting.
  • Educate personnel on the importance of timely report submission and escalations.
  • Collaborate with global companies for effective reporting.
  • Develop responses to inquiries from various global regulatory authorities regarding adverse event reports.
  • Produce various reports, including regulatory requests, marketing requests, and engineering requests.
Required Skills and Qualifications:
  • Hold a third-level qualification in Science or Engineering.
  • Gain significant experience in a regulated industry in a similar role.
  • Demonstrate in-depth knowledge of EU and US medical device regulatory requirements.
  • Display awareness of regulatory requirements in MDSAP countries.
  • Possess excellent communication and interpersonal skills.
  • Demonstrate proven problem-solving skills.
  • Proficient in computer skills, including Microsoft Office applications.
Additional Requirements:
  • High self-motivation is essential.
  • Willingness to travel on company business is required.

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