BD (Becton, Dickinson and Company) Regulatory Affairs Specialist I 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 RA representative on project teams
Coordinates the collection of data and information for regulatory submissions; writes the required regulatory submissions for new BAS products
Performs RA reviews for BAS labeling change requests
Coordinate the preparation of International Dossiers with the Product Teams and disseminate the dossiers to the appropriate parties
Travel as required (approximately 5%)
Understanding of US, CE, and international medical device regulations
High scientific, analytical evaluation skills
Good written and oral communication skills
Ability to work well within cross-functional teams
Education and/or Experience:
This position requires:
Bachelor’s Degree in Life or Engineering Science, Business, or equivalency
Two (2) years regulatory affairs experience or equivalency, or one (1) year with post-graduate degree
Regulatory experience with premarket notification submissions to FDA and 510(k) compliance
Demonstrated communication and human relation skills
The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.
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