BD (Becton, Dickinson and Company) Sr. Regulatory Affairs Specialist in San Jose, California
Job Description Summary
The Senior Regulatory Affairs Specialist is responsible for leading and supporting a variety of clinical pre and post market regulatory affairs activities. This includes tasks and deliverables such as U.S./EU product submissions, registration life cycle maintenance, and continual process improvement programs.
Job responsibilities include but are not limited to the following:
Coordinates and supports the preparation and maintenance of IVD regulatory submissions/files including EU technical files and U.S. FDA 510(k) submissions.
EU IVDR support including management of technical files, and review of reports and organization of regulatory documents and data.
Assessment of product changes to capture any impact to existing or in-process product registrations and letters to file for US and EU.
Assists in implementing department procedures and maintaining regulatory requirement matrices.
Works on problems of moderate complexity and diverse scope, including data analysis and ownership of task execution and completion.
Education and Experience:
Minimum of a Bachelor's of Science degree, preferable in Science or Engineering.
Minimum of 3 years' experience in Regulatory Affairs in a medical regulated environment
Knowledge and Skills:
Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.
Demonstrated organizational and planning skills, including process savvy, action-oriented, focused urgency and driving for results.
Ability to communicate and work in a diverse team environment; effective interactions with technical personnel.
Detail oriented, with emphasis on accuracy and completeness
Computer literacy (SAP, Microsoft Word / Excel / PowerPoint)
Primary Work LocationUSA CA - San Jose
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