Staff Regulatory Affairs Specialist (REMOTE)
Company: Becton Dickinson
Location: San Diego
Posted on: June 25, 2022
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Job Description:
Responsibilities Job Description SummaryThe Staff Regulatory
Affairs (RA) Specialist will represent Regulatory Affairs within
WWIPD platform of the Medication Delivery Solutions business unit
of Becton Dickinson (BD) on new product development, product
engineering, and other product development initiatives and
maintenance activities. 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. Duties and Responsibilities: The Staff RA Specialist will
act as the Regulatory lead on cross-functional product development
teams to achieve business goals. Provide teams with strategic and
tactical guidance regarding global regulatory requirements to
support product approvals/registrations. Independently leads
multiple long-term projects with some direction/support from
supervisor. Interacts with supervisor as required on activities,
issues, or turning points. Inspires effective unit dynamics and
imparts a sense of commitment to unit goals. Encourages and
empowers others to achieve outcomes. Develops global regulatory
strategies for WWIPD products. Prepares, submits, and maintains
510(k)s, technical files, and international regulatory submissions.
Reviews product design and change documentation, performs
regulatory assessments, and implements required regulatory actions.
Reviews labeling for compliance to labeling requirements, including
content, format, and regulatory registration impact, etc. Provides
regulatory review and approval for product marketing
communications. Provides regulatory guidance to functional teams
and business leaders as needed. Understanding of regulations for
sterile disposable products. Familiar with product
biocompatibility, sterilization, and packaging requirements.
Working knowledge of regulations for infusion pump sets, and
associated devices. SPECIFIC SKILLS & ABILITIES: Ability to read,
analyze, and interpret regulatory literature and documents. Ability
to effectively communicate information to peers and management.
Ability to translate regulations and guidelines into terms that
other functions can understand. Ability to define problems, collect
data, establish facts, and draw valid conclusions, and then
communicate the information both verbally and in writing to a
variety of audiences. Ability to solve practical problems based on
a variety of concrete variables in situations where only limited
standardization exists. Excellent writing skills; both formatting
as well as the development of a clear logic trail to develop
conclusions based on an understanding of factual evidence. Ability
to function under change. MINIMUM QUALIFICATIONS: Below are the
minimum qualifications for this position at this grade level. Other
factors are taken into consideration when deciding what position
and grade level to place an employee such as performance level,
capable contribution level and company need. Bachelor's degree,
preferably in the life sciences, and minimum of 3 years related
professional experience. Solid understanding and experience with
current FDA medical device regulatory requirements (e.g. 510k), ISO
standards related to the Medical Devices, EU MDD & MDR requirements
and country specific requirements where business group's products
are marketed. Strong background and history of representing RA in
cross functional projects with consistent record of successful
outcomes. Ability to prioritize optimally and coordinate
sophisticated information. Excellent interpersonal, communication
and analytical skills. Knowledge of Medical Device and disposable
design regulations. Ability to collaborate optimally with personnel
at all levels and functional boundaries. Ability to represent
Regulatory Affairs in multiple environments (i.e., Marketing,
R&D, etc.) For 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
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. PDN LI-PRO Primary Work LocationUSA CA - San
Diego TC Bldg C&D Additional Locations Work Shift Apply Save
Job PDN-968d01da-cb46-41e6-bcad-5211d165c5f8
Keywords: Becton Dickinson, San Diego , Staff Regulatory Affairs Specialist (REMOTE), Other , San Diego, California
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