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.