Medical Events Specialist I
$81,500–$141,300 year
On-siteAlameda, California, United States
Job Summary
Review medical complaints and gather information to determine reportability in accordance with regulations. Document filing decision rationale in the Complaint Handling System and ensure timely submission of reportable medical events to US, Canadian, EU, and global regulatory authorities. Monitor submitted vigilance reports and follow up on required actions while collaborating with customer service and investigation teams. Provide feedback to the Quality team to promote accurate documentation and adapt processes to align with updated regulatory requirements. Work within the Diabetes Care division in Alameda, CA, supporting the global Medical Events Group.
Required Qualifications
- Bachelors Degree in related field or an equivalent combination of education and work experience
- Minimum of 1 year of experience in Regulatory, Medical Events reporting or Quality
Desired Qualifications
- Ability to communicate at all levels with clarity and precision both written and verbally
- Excellent problem-solving and critical-thinking skills
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Multitasks, prioritizes and meets deadlines in timely manner
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