BD (Becton, Dickinson and Company) Spec II, Regulatory Affairs in Salt Lake City, 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, including clinical studies, addresses all regulatory requirements as well as objectives of the business. Requires data analysis, problem solving, and attention to detail. May provide leadership by assigning work and resolving complex problems.
The following items are to be carried out with minimal supervision:
Coordinate, prepare, and follow up with FDA Premarket Notification [510(k)] submissions in a timely manner.
Act as liaison with FDA regarding product clearance. Assess necessity for submitting a 510(k) application for proposed devicechanges. Prepareinternal “Non-Filing Justifications” (U.S.) for changes that do not require a 510(k) submission.
Prepare technical files for CE marking with appropriate input from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
Submit notifications to the Notified Body about significant changes to CE marked products in a timely manner.
Review/approve labeling, promotional and advertising materials to ensure regulatory compliance.
Review clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.
Represent RA in product life cycle development teams by reviewing, approving, and completing requirements.
Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary.
Represent RA in design teams and projects by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions.
Submit product listing to the FDA when deemed necessary.
Support International Registrations as it relates to product changes, new product launches, and/or product renewals
Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.
Mentor others through similar tasks as listed above
B.S. degree or higher, preferably in engineering, bioengineering, biology, or chemistry
At least 5 years medical device experience or at least 3 years medical device experience in Regulatory Affairs
At least 3 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, MDR
Experience with vascular access devices
Proficient in using Microsoft Office
Strong communication and project management skills
Must be able to handle multiple tasks
Attention to detail
510(k), MDD 93/42/EEC, MDR
21 CFR 820 - Quality System Regulation
Medical device standards and FDA guidance relevant to medical devices
Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction 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.
BD and Covid-19: To ensure the safety of our associates, BD supports remote work where possible. This position is based in the listed location but is temporarily remote-based due to Covid-19. Any offer of employment is contingent upon the candidate reporting to work at the site if/when associates are requested to return to the workplace. Local applicants are preferred; however, remote candidates will also be considered.
Primary Work LocationUSA UT - Salt Lake City BAS
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, or any other protected status.