Student Veterans of America Jobs

Welcome to SVA’s jobs portal, your one-stop shop for finding the most up to date source of employment opportunities. We have partnered with the National Labor Exchange to provide you this information. You may be looking for part-time employment to supplement your income while you are in school. You might be looking for an internship to add experience to your resume. And you may be completing your training ready to start a new career. This site has all of those types of jobs.

Here are a few things you should know:
  • This site is mobile friendly. You do not need a log-in or password to access information.
  • Jobs on this site are original and unduplicated and come from three sources: the Federal government, state workforce agency job banks, and corporate career websites. All jobs are vetted to ensure there are no scams, training schemes, or phishing.
  • The site is refreshed daily to remove out-of-date content.
  • The newest jobs are listed first, so use the search features to match your interests. You can look for jobs in a specific geographical location, by title or keyword, or you can use the military crosswalk. You may want to do something different from your military career, but you undoubtedly have skills from that occupation that match to a civilian job.
Mobile Logo

Job Information

BD (Becton, Dickinson and Company) Regulatory Affairs Specialist (Remote Optional) in Warwick, Rhode Island

Job Description Summary

Job Description

This position will be working in the BD Interventional Surgery Business Unit on implantable and absorbable devices. Under the guidance of the Director of Regulatory Affairs, the position will provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical device regulations in U.S. and global regions. Additionally, the position will provide regulatory support to marketed products and ensure company's regulatory compliance status.

Responsibilities:

  • Coordinate, prepare, and execute supplements and required reports to the US FDA with a focus on Class III devices including 30 Day Notices, 180 day supplements, annual reports in a timely manner. Act as liaison with FDA in support of these submissions and facilitate the building of responses to any requests for information from the FDA related to these submissions.

  • Assess necessity for reporting changes to FDA for proposed device modifications. Prepare robust reporting justifications for changes that do not require supplements or notices.

  • Assist Product Development and Quality Assurance in planning testing that will ultimately be used in regulatory submissions.

  • Coordinate and prepare technical files for submissions to notified bodies for timely CE marking of new and modified products, with appropriate input from supporting functions (R&D, Quality, Manufacturing, etc.).

  • Assist in the review and approval product labeling, promotional, and advertising materials to ensure regulatory compliance.

  • assist in updates to standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.

  • Coordinate and respond to requests for product information, and questionnaires requested by customers.

  • Remains current on regulations affecting BD products and keep the relevant team and supervisors informed about potential impact.

Qualifications

  • B.S. or equivalent with emphasis on material science or mechanical engineering. Professional certifications preferred.

  • 1-2 years of experience in medical devices required (must have experience in one of the following areas in medical devices: Regulatory Affairs, Quality or R&D).

  • Knowledge and experience with regulatory requirements for medical devices (IDE’s, PMA’s ,510(k)’s, CE mark technical files and design dossiers).

  • Good oral and written communications skills - analytical thinking and technical writing; ability to work on cross-functional teams; ability to manage several parallel deliverables.

  • Working knowledge of statistics and electronic documentation and information systems.

  • Ability and desire to travel as needed.

Knowledge, Skills, and Abilities:

  • Proficient in using Microsoft Word, Excel, PowerPoint, and Project.

  • Strong communication (written, oral) and project management skills.

  • Must be able to handle multiple tasks with attention to detail with limited supervision.

  • Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills.

  • Comprehensive knowledge of US medical device regulations, 21 CFR 820 -Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards, Good Laboratory Practice regulations.

  • Comprehensive knowledge of regulatory requirements for absorbable and implantable devices.

  • Comprehensive knowledge in new product regulatory strategies.

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

Primary Work LocationUSA RI - Warwick

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.

DirectEmployers