BD (Becton, Dickinson and Company) RA Specialist in San Diego, California
Job Description SummaryMaintains regulatory documentation and works with project teams to provide ongoing regulatory support. Develops regulatory strategy for product submissions and regulatory compliance activities. Develops and maintains domestic and international submissions and documentation. Reviews international and domestic labeling, marketing communications and product design documentation ensuring compliance with regulatory requirements. Provides regulatory guidance.
This job description does not promise or imply that the functions & responsibilities listed are the only duties or responsibilities to be performed or that the position may not change or be eliminated. Employees are always expected to follow their supervisors' instructions and to perform the tasks requested by their supervisors.
Maintains Technical Documentation to support CE Marking of MMS products.
Assists with Notifications of Change to the Notified Body as required.
Assists in the preparation of Business Unit procedures to ensure compliance with Regulatory and business requirements.
Provides information to regional RA employees for the registration of products with foreign regulatory agencies, on assignment.
Assist with RA projects and related tasks as requested.
Maintains budget records and provides monthly updates of the status.
Maintains regulatory databases/filing of regulatory documentation including: regulatory strategies, change notifications and responses, letters-to-file, etc.
Assists in the compilation/assembly of RA submissions as needed.
Prepares, submits and maintains 510(k)s, technical files and international regulatory submissions.
Reviews product design and change documentation.
Reviews domestic and international labeling for compliance to labeling requirements, including content, format, 510(k) and regulatory registration impact, etc.
Provides regulatory guidance as needed.
Primary Work LocationUSA CA - San Diego TC Bldg C&D
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