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BD (Becton, Dickinson and Company) Regulatory Affairs Associate in Tempe, Arizona

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.

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 August 22, 2027.

Position Summary:

The Regulatory Affairs (RA) Associate is an entry-level role for the RA Professional. The RA Associate will provide regulatory support for one or more product lines and/or region(s), including participation on new product development teams and continued support through the lifecycle of the product. The RA Associate may also help to prepare regulatory submissions required to market new or modified medical devices in global markets. The RA Associate is able to communicate regulatory issues to management to ensure the business is aware of opportunities, risks and concerns.

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

  • Reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications. Communicates changes to global regions and supports preparation of global notifications as needed.

  • Participates in core teams and provides guidance on regulatory requirements to product development teams, with guidance/support from management.

  • Supports preparation of dossiers and submission packages for regulatory agencies.

  • Supports strategic regulatory activities of a more senior RA team member.

  • Reviews advertising and promotional material for respective product line(s) and/or regions(s) as needed.

  • Maintains regulatory databases/systems with key regulatory data for respective product line(s) and/or region(s) as needed.

  • May participate in regulatory body audits in a supporting role.

  • Demonstrates data interpretation skills to provide solutions, draw conclusions and identify trends.

  • Completes day-to-day support for RA Systems.

Required Qualifications:

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

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

  • Ability to learn new technical concepts.

  • Good problem solving and analytical skills.

  • Good written and oral communication skills.

Preferred Qualifications:

  • Previous experience in the medical device industry.

  • Previous regulatory affairs experience, e.g., RA Internship.

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

  • Ability to complete assigned work with minimal supervision and ability to work independently.

  • Excellent writing and strong organizational skills.

Education and/or Experience:

  • Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field, or equivalent combination of related education and experience.

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations.

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID19. 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 https://jobs.bd.com/

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.

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PDN

Primary Work Location

USA AZ - Tempe Headquarters

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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