Manager, Clinical Complaints Specialist

Becton Dickinson Medical Devices • San Diego, CA

2d • Onsite

About The Position

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. 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. 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.

Requirements

• Registered Nurse with a bachelor’s degree or bachelor’s 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.

Nice To Haves

• 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, C‑suite, 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.

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 cross‑functional teams on adverse events to gather input on investigative details as part of the due‑diligence 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 post–site 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 questions—both clinical and technical—and identify when to route customers to other BD teams for customer support.
• Perform additional complaint‑related functions as directed by the manager.

Benefits

• At BD, we are strongly committed to investing in our associates—their 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 associates’ 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees