Medical Device Reporting Specialist

6 hours ago

Limerick, Limerick, Ireland beBeeCommunication Full time €60,000 - €70,000

**Job Title:** Regulatory Communications Specialist

Job Summary:

The Regulatory Communications Specialist serves as a key liaison between the manufacturer and regulatory authorities, assessing complaints for reporting purposes.

  • Assess customer complaints from global support and delivery centres to determine if events meet reporting requirements.
  • Utilize complaint software systems for processing and generating reports.
  • Liaise with regulators on all issues related to reporting.
  • Evaluate confirmed reportable events and escalate them in a timely manner.

Maintain an excellent understanding of medical device regulations and implement applicable requirements. Coordinate multiple projects simultaneously and provide regular updates. Serve as a liaison on regulatory issues between the manufacturer and international offices or distribution partners. Ensure compliance with regulations and perform additional duties as assigned.

Qualifications and Skills:

We are seeking candidates with a third-level qualification in Science/Engineering and several years of experience in a regulated industry. A thorough knowledge of EU & US medical device regulatory requirements is essential, along with knowledge of quality standards and practices in similar industries.

  • Good communication and interpersonal skills are required.
  • Proven problem-solving skills are necessary.
  • Proficiency in Microsoft Office and computer skills are expected.
  • Strong organisational skills and high self-motivation are necessary.

Occasional travel on company business may be required. If you have the skills and qualifications we are looking for, please apply.

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