Regulatory Affairs Specialist

Company: BD
Location: Tempe
Posted on: August 4, 2022

Job Description:

Responsibilities Job Description Summary Job Description Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. Excited to grow your career? We value our talented 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 a limited term assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through May 31, 2024. Regulatory Affairs (RA) Specialist will be responsible for the support and/or preparation of regulatory submissions required to market new or modified medical devices in both domestic and international markets. This responsibility entails development, execution 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. Essential / Key Job Responsibilities (including supervisory and/or fiscal):

• Assists or has ownership in the preparation of new product marketing submission for the FDA (510k, PMA).
• Maintains regulatory databases/systems for key regulatory data.
• Provides guidance on requirements to product development teams.
• Develops strategies for submissions to FDA and other regulatory agencies.
• Reviews Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and international regulations and standards. Sends out notifications of change to the Notified Body as required.
• Supports international regulatory requests.
• Assist in the preparation of division procedures to ensure compliance with Regulatory and Corporate requirements.
• Understands labeling global regulatory requirements. Reviews and approves ad/prom and labeling. Required Qualifications:
  • Ability to plan and schedule multiple priorities in a concurrent fashion.
  • Ability to review, collate and summarize scientific and technical data.
  • Excellent problem solving and analytical skills.
  • Good 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 supervision and ability to work independently.
  • This position also requires excellent writing and strong organizational skills. Preferred Qualifications:
    • Regulatory experience Education and/or Experience:
      • Bachelor s degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field.
      • Minimum of 0-2 years of RA related experience. F or certain roles at BD, employment is contingent upon the Company s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why join us? A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life s purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates. To learn more about BD visit 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. PDN Primary Work Location USA AZ - Tempe Headquarters Additional Locations Work Shift Apply Save Job

Keywords: BD, Tempe , Regulatory Affairs Specialist, Other , Tempe, Arizona