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 enhance product quality and improve business efficiency. 

• Ability to interface with regulatory bodies to present technical information.

• Comprehensive knowledge of quality systems and relationship to business.

• Ability to effectively manage time.

• Ability to handle multiple task assignments.

• Ability to translate quality requirements into product specifications.

• Ability to interpret regulations, corporate, division and department procedures.

• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures or governmental regulations. 

• Ability to write routine reports and business correspondence.

• Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.

• Ability to communicate well with individuals at all levels of the organizations.

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. 

• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. 

Physical Demands

While performing the duties of this job, the employee is regularly required to sit and talk or hear.  The employee is frequently required to use hands to finger, handle or feel.  The employee is occasionally required to stand and reach with hands and arms and lifts and/or moves up to ten pounds.  Employee is required to meet with other personnel in other areas of building.  Specific vision abilities required by this job include close vision.

Work Environment

This position works in a normal office environment.  The noise level in the work environment is quiet to moderate.  This position also has exposure to laboratory environment, which may require handling of all types of chemicals including those that present health, flammability, and reactivity hazards. 

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

Work Shift