BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Sandy, Utah

Job Description Summary

Job Description

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.

Education:

B.S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry

Experience:

  • 1-2 years Medical Device experience

  • Working knowledge of 21 CFR 820 – Quality System Regulation

  • Strong communication and organizational skills

  • Able to multi-task

Preferred:

  • 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

Skills:

  • Proficient in using Microsoft Word, Access, Excel

  • Strong communication and project management skills

  • Must be able to handle multiple tasks

  • Attention to details

Knowledge:

  • 510(k), MDD 93/42/EEC

  • 21 CFR 820 - Quality System Regulation

  • Medical device standards and FDA guidances

Primary Work LocationUSA UT - Sandy

Additional Locations

Work Shift

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