Strategic Liaison for Regulatory Compliance

1 week ago

Limerick, Limerick, Ireland beBeeMedicalDeviceRegulation Full time €68,030 - €85,550
Regulatory Communications Specialist

Overview

The Regulatory Communications Specialist acts as a communication conduit between manufacturers and local affiliates or regulatory authorities. This role involves assessing complaints for Regulatory Reporting, including Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS), field actions, and associated correspondence to applicable Regulatory bodies.

Responsibilities:

  • Assess complaints from global customer support and delivery centres for adequate information to determine if the event meets Regulatory Reporting requirements.
  • Utilize complaint software systems for processing complaints to/from customer support and delivery centres and QE Investigation functions.
  • Generate appropriate regulatory reports based on assessments.
  • Liaise effectively with regulators on all issues regarding regulatory reporting.
  • Ensure that confirmed reportable events are escalated to the appropriate personnel in a timely manner.
  • Communicate with other 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.
  • Input into the assessment of field action through the Health Risk Assessment process.
  • Assist in coordinating Field Action administration activities between manufacturers and distribution centres.
  • Closing out of complaints as necessary.
  • Input and adherence to the scheduling and management of Post Market Surveillance (PMS) plans and reports.
  • Maintain appropriate regulatory records to demonstrate compliance with applicable regulations.
  • Maintain 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 QSP 21 CFR Part 820 as required.
  • Coordinate multiple projects at one time and provide regular reports to regulatory management and others as required.
  • Serve as a liaison on regulatory issues between manufacturers and international offices/distribution partners.
  • Maintain and organise appropriate regulatory records to demonstrate compliance with applicable regulations.
  • Perform additional duties as assigned.

Qualifications:

  • A third-level qualification in Science/Engineering is desired.
  • A number of years' experience in a regulated industry in a similar role is required.
  • Thorough knowledge of 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 organisational skills.
  • High self-motivation.
  • Willingness and availability to travel on company business.
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