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