Job Description Summary

The Clinical Risk Specialist II will perform MDR/adverse event reporting, evaluate clinical use of product, analyze data to reduce occurrence/risk, analyze adverse events/complaint trends, and respond to regulatory inquiries. This position will ensure that all product complaints are documented, investigated, and reported in compliance to applicable Quality Systems regulations, ISO requirements, 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. 

Summary of position

The Clinical Risk Specialist II will perform MDR/adverse event reporting, evaluate clinical use of product, analyze data to reduce occurrence/risk, analyze adverse events/complaint trends, and respond to regulatory inquiries.  This position will ensure that all product complaints are documented, investigated, and reported in compliance to applicable Quality Systems regulations, ISO requirements, FDA regulations, and Corporate, Division, and international policies and procedures.

Responsibilities

• Determine whether a product malfunction or serious injury report needs to be filed with the FDA.  Determine whether a 30 Day or 5 Day MDR report is required. Write and/or approve MDRs submitted.

• Review and approve adverse event decision trees in Trackwise (Domestic and International). Approve vigilance/international competent authority report to authorities.

• Assess clinical risk of reported complaints using risk management tools (DFMEA), medical literature, or consultations with medical professionals.

• Review complaint and quality investigations related to manufacturing, design or clinical use issues.  Review and approve investigations performed by the manufacturing site or OEM Supplier.  Ensure consistency and attention to detail in performing and documenting complaint investigations.

• Analyze complaints and adverse events and communicate issues and resolutions to management. 

• Make clinical severity and risk assessments, classify and assign FDA device and patient codes.  Where appropriate, arrange for HHE by a medical professional.

• Coordinate and follow-up with customers, nurses, clinicians related to sensitive/escalated complaints.

• Research and identify a U. S. equivalent or similar device of international products for MDR reporting.

• FDA-MDR contact for responding to FDA inquiries.  Investigates, documents, and files adverse event reports (both domestic and international) for products marketed by BD UCC.

• Approve decision trees for vigilance reports/international competent authority.

• Generate weekly reports (highlight of complaints, Reportability Decisions, MDR and Supplemental Reports).

• Other duties as assigned.

Qualifications

Education

• Bachelor’s degree required. 

• Nursing degree preferred.

Experience

• 3 years of clinical experience preferred.

• 3 years in the medical device industry preferred (including experience in complaint handling and MDR/adverse event reporting).

• Experience in complaint handling software (TrackWise or equivalent), Access Databases, and Excel (Pivot Tables and Charts).

Knowledge

• Extensive knowledge of medical device regulations, industry or international standards, including management responsibility. 

• Extensive knowledge of Quality Systems regulations, ISO requirements, FDA regulations, and international policies and procedures.

Skills and Abilities

• Advanced Microsoft Office skills preferred.

• Excellent communication skills (verbal, written, and presentation).  Understands how to present information dependent upon the level of the audience.

• Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to e