Manager, Regulatory Affairs

Job Description SummaryJob DescriptionThis position is responsible for the preparation of regulatory submissions required to market new or modified medical devices in the U.S., Europe, and internationally and related regulatory affairs activities, such as development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business. Requires the analysis of data, problem solving analysis and in depth evaluations of various factors. 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/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.

Submit notification 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.

Reviews 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 and/or new product launches Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.

Manage and mentor others through similar tasks as listed above

Requirements:B.S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistryExperience:3-5 years Medical Device or related industry experience required

Working knowledge of industry consensus standards and FDA guidance

Preferred:

At least 2-4 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

Regulatory Affairs Certified RAC (RAPS)

Experience with vascular access devices and central lines

​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

21 CFR 820 - Quality System Regulation

Medical device standards and FDA guidance relevant to medical devices.

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.#LI-PROBD 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.Primary Work LocationUSA UT - Salt Lake City BASAdditional LocationsWork ShiftBecton, 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.