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.

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

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 teh 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.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, 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 that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA GA - Covington BMD

Additional Locations

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