Responsibilities include, however are not limited to:
Work with a team to meet the requirements in generating periodic PMS related reports
Participate in projects to align with BD Quality, MDD/MDR strategies and regulatory submissions
Identify gaps and maintain PMS processes in compliance with global regulations
Participate in PMS planning and reporting
Extract and generate PMS and operational performance data necessary for generating applicable reports.
Coordinate and provide oversight in the analysis of PMS data
Identify and escalate instances when products are not achieving the intended performance based upon anticipated levels of frequency and/or severity
Identify and evaluate new failure modes when encountered
Maintain procedures, as necessary
Support responding to requests for additional information from competent authorities, registries and notified bodies
Work cross-functionally with Quality, Regulatory, Clinical Affairs, and Operations departments to fulfill ad-hoc data requests and deliver detailed analysis of PMS data
Develop and maintain knowledge of support systems including Master Control, JDE
Performs other related duties and responsibilities as assigned
Ability to travel up to 5% of the time
Requirements
Required Qualifications
Apply project management tools to ensure reports are submitted based on the commitment timelines
Ability to make and present risk-based decisions
Strong interpersonal skills
Problem solving ability
Ability to create, review and coordinate reports based on established guidelines and regulatory requirements
Oral and written presentation skills
Ability to provide analysis within strict timeline requirements and assuming accountability toward delivering on agreed upon commitments
Education and/or Experience
Requires a minimum of a bachelor's degree, Engineering Degree, or degree in a technical field
Proficient in Windows OS, Microsoft Office Suite
Proficient in Excel in manipulation of data
Preferred Knowledge and Skills
Medical device experience working with Class l, ll, and lll devices
Experience in technical writing and project management
Ability to develop & maintain dashboards using BI tools
PHYSICAL DEMANDS
Work Environment:
#CLOLI
Why Join Us?
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit http
Benefits
Health insuranceRemote work options
Additional Information
We are the people who give possibilities purpose
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.
Job Description
Becton Dickinson · - Tempe Headquarters, AZ