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BD (Becton, Dickinson and Company) Spec II, Regulatory Affairs in Salt Lake City, 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, 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

Required Qualifications:

  • 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

Preferred Qualifications:

  • 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

Skills:

  • Proficient in using Microsoft Office

  • Strong communication and project management skills

  • Must be able to handle multiple tasks

  • Attention to detail

Knowledge:

  • 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

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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