BD
Job Description Summary
The Adverse Events & Risk Analyst I on the Clinical Team will be responsible for determining the reportability and conducting evaluations of adverse events. This role involves assessing the clinical use of products, analyzing data to minimize occurrence and risk, and identifying trends in adverse events and complaints. The Analyst will ensure that all product complaints are thoroughly documented, investigated, and reported in compliance with applicable Quality Systems regulations, ISO standards, FDA regulations, and Corporate, Division, and International policies and procedures. Responsibilities
MDR Reporting: Assess product complaints for FDA reportability; determine and submit 30-Day or 5-Day MDRs. Complaint Intake: Collaborate with external service providers to ensure timely and accurate documentation. Decision Tree Review: Approve adverse event decision trees in Trackwise for U.S. complaints. Complaint Analysis: Review complaints related to manufacturing, design, or clinical use; ensure consistent documentation. Data & Risk Analysis: Analyze complaint trends and conduct clinical severity and risk assessments; assign FDA codes. Regulatory Research: Identify U.S. equivalents for international products for MDR reporting. Process Improvement: Provide feedback and drive updates to procedures and documentation. Legal Support: Review and approve Litigation MDRs; provide updates to legal teams. Other Duties: Perform additional tasks as assigned. Qualifications
Education: Bachelor’s degree required. Experience: Preferred background in FDA-regulated industries, complaint handling, MDR/adverse event reporting. Software: Proficiency in Microsoft Office, Trackwise (or equivalent), Access, and Excel (Pivot Tables/Charts). Regulatory Knowledge: Familiarity with 21 CFR Parts 803, 820, 806, ISO 13485, and related standards. Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time. Skills
Strong verbal and written communication. Effective time management and prioritization. Ability to interpret regulations and quality requirements. Detail-oriented with strong documentation and proofreading skills. Workplace & Policy
BD emphasizes on-site collaboration; a minimum of 4 days of in-office presence per week may be required for most roles to support culture and operations. Remote or field-based positions will have different arrangements indicated in the job posting. For certain roles, employment is contingent upon proof of full COVID-19 vaccination. In some locations, testing may be available or required. Requests for accommodation will be considered pursuant to applicable law. Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and encourages you to bring your authentic self to work. We help each other be great, do what’s right, hold each other accountable, and learn and improve every day. BD invites you to join and help reinvent the future of health. To learn more about BD visit
https://bd.com/careers Job Details
Primary Work Location: USA GA - Covington BMD Employment type: Full-time Job function: Business Development and Sales Industries: Biotechnology Research, Medical Equipment Manufacturing, and Research Services
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The Adverse Events & Risk Analyst I on the Clinical Team will be responsible for determining the reportability and conducting evaluations of adverse events. This role involves assessing the clinical use of products, analyzing data to minimize occurrence and risk, and identifying trends in adverse events and complaints. The Analyst will ensure that all product complaints are thoroughly documented, investigated, and reported in compliance with applicable Quality Systems regulations, ISO standards, FDA regulations, and Corporate, Division, and International policies and procedures. Responsibilities
MDR Reporting: Assess product complaints for FDA reportability; determine and submit 30-Day or 5-Day MDRs. Complaint Intake: Collaborate with external service providers to ensure timely and accurate documentation. Decision Tree Review: Approve adverse event decision trees in Trackwise for U.S. complaints. Complaint Analysis: Review complaints related to manufacturing, design, or clinical use; ensure consistent documentation. Data & Risk Analysis: Analyze complaint trends and conduct clinical severity and risk assessments; assign FDA codes. Regulatory Research: Identify U.S. equivalents for international products for MDR reporting. Process Improvement: Provide feedback and drive updates to procedures and documentation. Legal Support: Review and approve Litigation MDRs; provide updates to legal teams. Other Duties: Perform additional tasks as assigned. Qualifications
Education: Bachelor’s degree required. Experience: Preferred background in FDA-regulated industries, complaint handling, MDR/adverse event reporting. Software: Proficiency in Microsoft Office, Trackwise (or equivalent), Access, and Excel (Pivot Tables/Charts). Regulatory Knowledge: Familiarity with 21 CFR Parts 803, 820, 806, ISO 13485, and related standards. Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time. Skills
Strong verbal and written communication. Effective time management and prioritization. Ability to interpret regulations and quality requirements. Detail-oriented with strong documentation and proofreading skills. Workplace & Policy
BD emphasizes on-site collaboration; a minimum of 4 days of in-office presence per week may be required for most roles to support culture and operations. Remote or field-based positions will have different arrangements indicated in the job posting. For certain roles, employment is contingent upon proof of full COVID-19 vaccination. In some locations, testing may be available or required. Requests for accommodation will be considered pursuant to applicable law. Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and encourages you to bring your authentic self to work. We help each other be great, do what’s right, hold each other accountable, and learn and improve every day. BD invites you to join and help reinvent the future of health. To learn more about BD visit
https://bd.com/careers Job Details
Primary Work Location: USA GA - Covington BMD Employment type: Full-time Job function: Business Development and Sales Industries: Biotechnology Research, Medical Equipment Manufacturing, and Research Services
#J-18808-Ljbffr