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BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Salt Lake City, Utah

Job Description Summary

Job Description

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We value our hardworking employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply!

Our people make all the difference in our success.

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 direction:

  • 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 device changes. Prepare internal “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.

  • Lead and mentor others through similar tasks as listed above

Education and Experience Required:

  • This position requires a Bachelor's Degree or higher, with a preference for degrees in law, engineering, bioengineering, biology, or chemistry

  • The incumbent is helpful to have a minimum of 2 years employment in the areas of product registration, compliance, or quality systems; or combination of education and experience determined to be equivalent.

  • Experience in Regulatory Affairs is preferred.

  • Ability to plan and schedule multiple priorities in a concurrent fashion.

  • Ability to review, collate, and summarize scientific and technical data.

  • Ability to handle master documents, drawings, and specifications with a high degree of confidentiality.

  • Excellent problem solving and analytical skills.

  • Excellent written and oral communication skills.

  • Detail-oriented, methodical, and able to handle regulatory information and submissions with a high degree of accuracy.

  • Complete work with minimal direction and have the ability to work independently.

  • Knowledge of U.S. and/or international medical device regulations is preferred.

  • Basic computer skills (Windows environment)

  • Intercultural communication skills desirable.

  • Regulatory Affairs Certified RAC (RAPS) is preferred.

  • Experience with active medical devices, vascular access devices and/or central lines is preferred.

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.

#LI-PRO

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 Location

USA UT - Salt Lake City BAS

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, or any other protected status.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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