Manager, Clinical Complaints Specialist

Job Description Summary The Manager, Clinical Complaints Specialist serves as a leader within the MMS Designated Complaint Handling Unit (DCHU), responsible for overseeing a team dedicated to gathering and assessing complaint information and adverse event determination/MDR reportability. Reporting to the Sr. Quality Manager, this role provides leadership and oversight for adverse event reporting and the clinical assessment of complaints. 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 healthu2122 is our Purpose, and itu2019s no small feat. It takes the imagination and passion of all of usu2014from design and engineering to the manufacturing and marketing of our billions of MedTech products per yearu2014to 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 youu2019ll be supported to learn, grow and become your best self. Become a maker of possible with us. Job Summary: The ideal candidate will demonstrate proven leadership capabilities with a strong track record of driving team success and achieving organizational goals. They will possess a natural aptitude for mentoring and developing talent, paired with strong critical-thinking skills, sound decision-making, and the ability to navigate ambiguity. This individual operates effectively with a high level of autonomy, manages multiple competing priorities, and is committed to continuous learning. Clear and effective communication across diverse audiences is essential, as is the ability to build strong relationships and collaborate with both internal and external stakeholders. The candidate should exhibit exceptional attention to detail and accuracy, thrive in team-oriented environments, and display strong interpersonal skills. Independent judgment, ownership of outcomes, and experience driving process improvements are also highly valued. Responsibilities: + Manage, mentor, and orient the team of Clinical Specialists; assist with outbound follow-up phone calls (in lieu of email) to healthcare facilities to obtain pertinent information in a timely manner. + May serve as a Subject Matter Expert (SME) and assist with data requests and crafting responses during internal audits and inspections by notified bodies. + Collaborate with cross-functional team and support internal and external customer activities related to product complaints and gathering of additional information on reported events. + Monitor group email inboxes and ensure inbound emails are reviewed and processed or forwarded promptly. + Escalate and collaborate with BD crossu2011functional teams on adverse events to gather input on investigative details as part of the dueu2011diligence process for collecting facts from healthcare facilities. + Work collaboratively with the BD investigative lab to promptly relay pertinent information gathered from customer calls or correspondence. + Review and summarize medical journal articles received throughout BD to assess whether they represent reportable adverse events involving BD Pyxis Dispensing Solutions and BD Alaris Systems for medical device reporting. + Review postu2013site visit reports from BD teams; provide input on complaint determinations and MDR reportability. + Expedite death-related eMDR submissions for clinical and legal review, as needed, to ensure timely FDA reporting. + Effectively manage multiple tasks in a fast-paced environment, with a strong emphasis on timely MDR submissions. + Work overtime as needed to meet regulatory submission timeframes. + Collaborate with cross-functional teams regarding customer questionsu2014both clinical and technicalu2014and identify when to route customers to other BD teams for customer support. + Perform additional complaintu2011related functions as directed by the manager. Minimum Requirements: + Registered Nurse with abacheloru2019sdegree or bacheloru2019s degree in health-related field or biomedical engineering. + Current active RN license required if with nursing degree. + Ability to exercise independent judgment and discretion. + Demonstrated ability to balance multiple tasks and prioritize work. + Ability to be effective in complex projects with ambiguity and/or rapid change. + Orientation for detailed work, with emphasis on accuracy and completeness. Preferred Experience: + A minimum of 3 years of professional experience as an RN in a clinical or direct patient care setting or relevant work experience. For non-RNs, a minimum of 5 years of experience in medical device quality. + Experience with medical device complaint handling and MDR reporting. + Experience with the BD Pyxis Dispensing Solutions and the BD Alaris System. + Experience as a direct people leader. + Comfort interfacing with all levels of the organization and with customers across healthcare roles (nursing staff, physicians, pharmacists, Biomed, Cu2011suite, risk management). + Knowledge of MedTech regulatory standards (e.g., 21 CFR 803, 21 CFR 820). + Experience with software including MS Office (Word, PowerPoint, Excel, Outlook). + Experience with TrackWise, SAP, Salesforce, and MS Teams. + Ability to multi-task and operate in a fast-paced environment with strong attention to timely eMDR submissions. 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 Companyu2019s 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 BDu2019s 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. Itu2019s also a place where we help each other be great, we do whatu2019s 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, youu2019ll 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 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 . Primary Work Location USA CA - San Diego Bldg A&B Additional Locations USA CA - San Diego TC Bldg C&D, USA UT - Salt Lake City, USA UT - Sandy Work Shift At BD, we are strongly committed to investing in our associatesu2014their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You (. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associatesu2019 progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $126,600.00 - $208,900.00 USD Annual Becton, 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: 2026-05-02