Medical Device Regulatory Liaison

2 days ago

Limerick, Limerick, Ireland beBeeRegulatory Full time €55,000 - €70,000
Regulatory Communications Specialist

Overview

The Regulatory Communications Specialist plays a key role as a communication liaison between manufacturers and regulatory authorities. This position is responsible for assessing complaints to determine if they meet reporting requirements, generating regulatory reports, and liaising with regulators.

Key Responsibilities:

  • Assessing complaints from customer support and delivery centers for adequate information to determine if events meet reporting requirements.
  • Generating appropriate regulatory reports based on assessments.
  • Liaising effectively with regulators on all issues related to regulatory reporting.
  • Escalating confirmed reportable events to the appropriate personnel in a timely manner.
  • Communicating with other companies globally as necessary for reporting.
  • Generating responses to inquiries on AE reports from various global regulatory authorities.
  • Generating various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests.
  • Inputting into the assessment of field actions through the Health Risk Assessment process.
  • Assisting in coordinating field action administration activities between manufacturers and distribution centers.
  • Closing out complaints as necessary.
  • Inputting and adhering to the scheduling and management of Post Market Surveillance (PMS) plans and reports.
  • Maintaining appropriate regulatory records to demonstrate compliance with applicable regulations.
  • Maintaining an excellent understanding of global medical device regulations.
  • Responsibility for implementing applicable regulatory requirements in accordance with ISO 13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA QSR 21 CFR Part 820 as required.
  • Coordinating multiple projects at one time and providing regular reports to regulatory management and others as required.
  • Serving as a liaison on regulatory issues between the manufacturer and the international office and/or distribution partner.
  • Maintaining and organizing appropriate regulatory records to demonstrate compliance with applicable regulations.
  • Performing additional duties as assigned.
  • Ensuring that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf.
  • Delegate for the Regulatory Communications Team Lead.

Requirements:

  • Third-level qualification in Science or 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/practices or similar regulated industries.
  • Good communication and interpersonal skills.
  • Proven problem-solving skills.
  • Good computer skills, including knowledge of Microsoft Office.
  • Proven organizational skills.
  • High self-motivation.
  • Willingness and availability to travel on company business.

Benefits:

  • Excellent opportunity to work with a leading manufacturer.
  • Challenging and dynamic role.
  • Opportunity to develop skills and knowledge in regulatory affairs.

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