Clinical Supervisor

Job Description SummaryThis position supervises the Clinical team within the Field Assurance Department for the UCC (Urology and Critical Care) business. The role provides a high degree of confidence that all product complaints received on products are assessed for compliance to applicable Quality Systems regulations, ISO requirements, FDA regulations, and Corporate, Division, and International policies and procedures.Job DescriptionBe part of something bigger!BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.SCHEDULE: HYBRID 2 Days in the office and 3 Days homeEssential Duties and Responsibilities:Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department.Responsible to maintain the training requirements for staff, including job position requirements, and evidence of training completion for associates.Responsible to meet quality objective goals as defined annually in support of monthly and quarterly metrics and business strategies.Ensure product complaints are documented properly such that, they are reported in Quality System regulations and corporate, division, and international procedures.Oversee Adverse Event reporting for Medical Device Reports (MDRs) and EU MDR vigilance reporting (FDA contact for MDRs). Manufacturer Investigation Reports (MIR) in compliance with applicable regulatory fluence direct reports to:Critically think and analyze complaints to ensure accurate report ability determination while achieving on-time MDR reporting.Clinical consultant evaluating use of products and risks associated with complaints to determine device malfunction, serious injury, or patient death.Analyze all patient deaths and follow up with complainant to determine relatedness to device.Assess medical journals/literature to identify complaint and adverse event data.Highly variable operations performed daily, from complex regulatory decisions to routine administrative functions. Interpret written regulations, policies and procedures. In some instances, only judgment based on past experience can be used. Collaborate with Medical Affairs to formulate clinical survey questions that impact complaint and adverse event reporting.Decisions made could have significant regulatory and financial implications. Which may include but are not limited to:Review responses to additional information requests for FDA inquiries, notified bodies and competent authorities.Assist with audit/FDA inspection readiness and function as the subject matter expert (SME) for complaints/adverse events during audits (BSI/MDSAP, FDA, etc.).Formulate Audit Action Plans (AAPs) and Corrective and Preventive Actions (CAPAs) for quality non-conformances.Conduct complaint clinical evaluation training on Urology & Critical Care products for new hires within own team and across Field Assurance organization.The Requirements are representative of the Knowledge, Skill and/or Ability required.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:Verbal communication skills and presentation skills:Create and understands how to present information dependent upon the level of the audience.Technical writing skills:Create reports, presentations, metrics, procedures, forms, flowcharts, quality plans, quality agreements, etc. and review and approve documentation, as required.Management skills:Prioritize resources based on changing business needs.This position is required to partner and lead across other functions within the Business Unit without direct reporting structures into those functions. Influence and the ability to clearly define the business and compliance requirements are key to the success of the group and the puter skills:Create and run technical documents, as needed; ability to use electronic communication, time management, ERP and EDMS systems.Knowledge of medical device regulation, industry, and international standards:Ability to understand Organization, Corporate, Business Unit, and other Quality Systems and be able to implement systemic changes to enhance quality processes and improve business results.Knowledge and demonstrated use of Document Control, Training, and Document Management practices.Ability to interpret Regulations, Organization, Corporate, Business Unit, and Department prehensive knowledge of regulatory requirements, MDR, and EU MDR requirements.Ability to serve in leadership roles on projects or assignments.Education and or Experience;BS degree required in Engineering, Science, or Medical professional field, higher education a plus.Minimum of 5 years experience with an FDA regulated industry.Post-market surveillance or complaint handling experience in medical or pharma industry with reporting experience, highly preferred.For certain roles at BD, employment is contingent upon the Companys 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 BDs 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 empowers you to bring your authentic self to work. Here our associates can fulfill their lifes purpose through the work that they do every day.You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components is designed to support the varying needs of our diverse and global associates.To learn more about BD visit /Becton, Dickinson, and Company are an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate based on 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, or any other protected status.PDNPrimary Work LocationUSA GA - Covington BMDAdditional LocationsWork ShiftBecton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

Created: 2025-09-06