Job Description Summary

The Clinical Specialist is responsible for gathering facts from clinical end-users, biomedical engineers, risk managers, and other key stakeholders on reported issues related to the BD Alaris™ System. The individual must have a customer-centric focus and a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process. The Clinical Specialist plays a significant role in obtaining the correct and complete information on adverse events to support the assessment and determination of MDR reportability.

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 o ur 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.

Responsibilities:

In this role, the Clinical Specialist will be working primarily with the Designated Complaints Handling Unit's (DCHU) Clinical Specialist Team and HCL associates. The main responsibilities will include:

• Performs primarily outbound follow-up phone calls (in place of emails) to the healthcare facility on adverse event complaints to quickly gain pertinent information.

• Works with HCL associates by responding to their queries on complaints record processing and reportability determination.

• Collaborates with professional services to obtain investigative details on complaints from the healthcare facility.

• Works collaboratively with DCHU Investigations Team to quickly pass on any pertinent details from customer calls and other forms of correspondence.

• Facilitates expeditious processing of death and serious injury complaint records while ensuring that the adverse event information is comprehensive and meets target timeframes for electronic medical device report (eMDR) submission and complaint record closure.

• Responsible for reviewing adverse events to determine if it meets the criteria of a 5-day Reportable Event and escalates to the 5-day Reportability Review Board when appropriate.

• This position will be a subject matter expert for audits on assessments of adverse events.

• Responsible for reviewing draft initial and supplemental eMDRs on death or serious injury events, including IMDRF coding structures from IMDRF Annex A through G, with an additional focus on Health Effect coding (Annex E & F).

• Responsible for complaint escalation when appropriate by collaborating with various internal BD teams such as the investigation team, legal, engineering, escalation management, and executive leadership.

• Reviews medical literature, journals, articles, and other reports received throughout BD on Alaris Systems to assess whether they represent a complaint and contain a reportable adverse event for medical device reporting.

• Reviews site visit information from on-site teams and assesses customer feedback that needs to be captured as product complaints.

• Submits Death or Serious Injury (DorSI) Notification Report via email to notify the BD internal teams.

• Participates in the periodic review and revision of MDR Reportability Guidelines to incorporate newly identified failure modes and reportability determinations, expediting the procedural changes through document control.

• Reviews customer feedback involving product enhancement requests (PER) to determine if it meets the criteria of a product complaint. Requests for product enhancements are then forwarded to PER team.

• Overtime may be required on occasion to meet regulatory submission time frames.

Qualifications:

• Bachelor's Degree in Biomedical Engineering/Clinical Laboratory Science or Bachelor's Degree in Nursing (BSN). Must be a Registered Nurse for BSN applicants.

• A minimum of 3 years of professional experience directly related to the degree.

• Specific knowledge of the Alaris System, preferred.

• Knowledge of FDA and international regulatory requirements, preferred.

• Must be comfortable interfacing with all levels of the organization and with customers at various positions in health care (clinical staff, Biomed, C-suite, risk management).

• Must have effective interpersonal, telephone, and email communication skills.

• Highly preferred: TrackWise, SAP, and MS Teams is highly preferred.

• Working experience with various software programs, including MS Office (Word, PowerPoint, Excel, and Outlook), is required.

• Ability to multi-task and work in a fast-paced environment with critical importance on timely eMDR submissions.

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.

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. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

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/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.

PDN

Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

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 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 offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

Salary Range Information

$96,600.00 - $159,300.00