BD (Becton, Dickinson and Company) Regulatory Affairs Specialist I - MDR in Salt Lake City, Utah
Category: Medical Device/Regulatory Affairs
Job ID: 2018-11577
Career Level: experienced
Division: Salt Lake City, UT/ Vascular Access Devices - MDS
Location: Salt Lake City,Utah,United States
BARD has now joined 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%).
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.
International markets experience
Language - Spanish or Portuguese
The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.
Additional Desirable Qualifications Skills and Knowledge:
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.
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