BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Sandy, Utah
Job Description Summary
This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysis, problem solving, and attention to detail.
Represent RA on project teams by providing regulatory guidance throughout the product development cycle, coordinate team inputs for regulatory submissions, and review and approve applicable design control documentation.
Support International Product Registrations, including new registrations, re-registrations, and product change registrations/notifications.
Coordinate and collect specific registration information with R&D, Quality, Medical, Manufacturing, etc.
Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal “Non-Filing Justifications” (U.S.) for changes that do not require a 510(k) submission.
Support senior Regulatory personnel in preparing Premarket Notification [510(k)] submissions, as needed.
Prepare/update technical files for CE marking with appropriate input from various functions (R&D, Quality, Medical, Manufacturing, etc.).
Submit notifications to the EU Notified Body for significant changes to CE marked products.
Maintain Regulatory documentation.
Support special projects, as needed.
B.S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry
1-2 years Medical Device experience
Working knowledge of 21 CFR 820 – Quality System Regulation
Strong communication and organizational skills
Able to multi-task
At least 1-2 years Regulatory Affairs experience in Medical Device regulations
Demonstrated success in taking products through FDA and EU Notified Bodies
Working knowledge of 510(k), MDD 93/42/EEC
Working knowledge of standards and FDA guidances
International product registration experience
Proficient in using Microsoft Word, Access, Excel
Strong communication and project management skills
Must be able to handle multiple tasks
Attention to details
510(k), MDD 93/42/EEC
21 CFR 820 - Quality System Regulation
Medical device standards and FDA guidances
Primary Work LocationUSA UT - Sandy
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