Senior Clinical Risk Specialist

2 weeks ago

Sligo, Sligo, Ireland beBeeMedical Full time €60,500 - €86,100

Job Summary

We are seeking a Medical Safety Analyst to support our Medical Safety & Surveillance team. As an individual contributor, you will play a key role in reviewing, assessing, and summarizing medical device complaint information for complex investigations and risk assessments.

  • Create and present medical safety analyses, reports, and assessments both orally and in writing to internal and external stakeholders.
  • Gather, analyze, and present findings from Medical Safety and Surveillance complaint data regularly, including tracking and trending activities.
  • Ensure compliance with departmental SOPs and contribute to drafting new SOPs as needed.
  • Develop medical safety training materials and deliver presentations to a broad international audience.
  • Assist in preparing literature searches, data analyses, and regulatory documentation supporting medical device registration.
  • Conduct literature reviews, summarize findings, and present information to cross-functional teams.
  • Support colleagues with medical device complaint processing and conduct follow-up calls with customers to gather adverse event details.
  • Determine complaint reportability to regulatory authorities and ensure timely vigilance reporting.

Requirements

To be successful in this role, you should have a Bachelor of Science or related health science degree, preferably with RAC certification. A minimum of 2-3 years of experience in the medical device industry is required, with a strong background in data review, risk assessment, DFMEA review, and patient safety activities.

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