BD (Becton, Dickinson and Company) Associate Regulatory Affairs Specialist in Salt Lake City, Utah
Job Description Summary
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.
Vascular Access Devices, a sub-business unit of Medication Delivery Solutions, focuses on developing, manufacturing, and distributing high-quality medical devices used by clinicians throughout the worldwide healthcare industry to access a patient’s vasculature. Our devices assist in the delivery of chemotherapy, blood products, antibiotics, and nutrition.
Summary of Position with General Responsibilities:
This position implements C.R. Bard domestic and international regulatory affairs (RA) procedures. This position may also act as a liaison to Corporate Law Department, providing requested information.
Essential job Functions:
The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.
Serves as an Associate RA representative on project team
Supports senior Regulatory personnel in preparing new product marketing submission for the FDA (510k, PMA)
Maintains Regulatory Affairs documentation
Supports international Regulatory requests
Sends out notifications of change to the Notified Body as required
Supports divisional and corporate litigation requests as needed
Assist in the preparation of division procedures to ensure compliance with Regulatory and Corporate requirements
Performs on special projects as required
Ability to plan and schedule multiple priorities in a concurrent fashion
Ability to review, collate and summarize scientific and technical data
Excellent problem solving and analytical skills
Good written and oral communication skills
Ability to work well within cross-functional teams
Complete work with minimal supervision and ability to work independently
Education and/or Experience:
This position requires:
Bachelors Degree in Life or Engineering Science, Business, or equivalency
No previous regulatory experience is required
Good writing and strong organizational skills required
Demonstrated communication and human relation skills
This position is in an office environment and requires the incumbent to perform general office functions.
The ideal candidate must be able to work in a team oriented, fast paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
Primary Work LocationUSA UT - Salt Lake City BAS
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