Job Description Summary

　　Reporting to the Engineering Manager or delegate, the Device Regulation Project Coordinator's role is to drive plant implementation for the EU Region MDR/IVDR regulatory requirements (European Union Medical Device Regulation / In vitro diagnostic medical device regulation). Must be able to effectively plan/track, collaborate, and manage the actions of different functions to deliver compliance to these regulations by the required deadlines. In addition, this role will personally handle all facets of the regulatory changes as the plant/site project leader, including communicating material and process information to Specimen Management Business Group project team, executing equipment specification, procurement, implementation, and validations, and coordinating packaging/ material procurement and inventory run out with Procurement as appropriate.

　　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 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.

　　ESSENTIAL FUNCTIONS:

　　The essential functions of this position include but are not limited to:

　　Lead all EU MDR/IVDR (European Union Medical Device Regulation / In vitro diagnostic medical device regulation) activities for site.Technical assessment of UDI (unique device identification) and Date of Manufacture to all levels of packaging.Identifying gaps against EU MDR/IVDR requirements and current packaging/labelling.Prepare accurate timelines for all program and project tasks.Liaise with the quality, regulatory, facilities, production, and marketing departments to obtain their input and / or support to ensure program is successfully initiated and validated within time frame and budget.Supports and advises plant leadership on MDR/IVDR program.Acts as link between Franklin Lakes Specimen Management Business Group Project Team and plant resources (Plymouth, Broken Bow, Sumter, Juncos); provide communication directly with IDC. One person point of contact for all EU MDR/IVDR information collection and distribution, including but not limited to - validations, process maps, process aids and other information as needed.Actively seeks opportunities to and liaise with other PAS sites to share learnings and copy best practices.Ability to handle several assignments (project and process duties) simultaneously and coordinate and execute multiple facets of projects; including, but not limited to equipment procurement, implementation, and validation.Accountable for spending (capital and expense) within approved limits of program.Coordinate "system" activities such as changes to SAP and BOM's.

　　Documentation review for content, accuracy, and completeness, including:

　　LabelsIFU's (instructions for use)Manufacturing section of technical documentsCoordinate activities with planning and production groups to ensure minimize changeovers and inventory write-off of labels and packaging inventory.

　　OTHER RESPONSIBILITIES:

　　Other responsibilities of this position include but are not limited to:

　　Complies with, and responsible for enforcing, all local, state, federal and BD safety regulations, policies/procedures.Complies with all local BD quality policies/procedures/practices through consistent application of sound Quality Assurance principles. Ensures compliance through appropriate communication, training, and education of sound Quality Assurance principles. Responsible for the activities and programs as defined for this position in the Quality Systems Manual - BD Broken Bow.Performs other job-related duties as assigned.Observes all safety, environmental and quality system standards.All requirements are subject to possible modification to reasonably accommodate individuals with disabilities.Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the incumbent will possess the abilities or aptitudes to perform each duty proficiently.This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship.

　　Supervision:

　　This position reports directly to the Sr. Engineering Manager.

　　This position has no direct reports

　　Education:

　　Bachelor's degree required, other relevant experience will be considered (see below).

　　Experience:

　　Experience in medical device manufacturing is preferred and must have a proven track record in implementing change.Experience in manufacturing , or quality, or material control.Device regulation knowledge is a plus.Preferred knowledge of design control and validation processes.SAP knowledge and experience is a plus.

　　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.

　　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 NE - Broken Bow

　　Additional Locations

　　Work Shift

　　NA (United States of America)