Sr. Regulatory Affairs Specialist - Medical Device
Company: Abbott Laboratories
Location: Irving
Posted on: January 12, 2021
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Job Description:
Abbott is a global healthcare leader that helps people live more
fully at all stages of life. Our portfolio of life-changing
technologies spans the spectrum of healthcare, with leading
businesses and products in diagnostics, medical devices,
nutritionals and branded generic medicines. Our 107,000 colleagues
serve people in more than 160 countriesABOUT ABBOTT DIAGNOSTICS:
The key to successful treatment and full recovery is often fast,
accurate diagnosis. Abbott's life-changing tests and diagnostic
tools provide insights that enable smarter, faster decisions and
transform the way the world is managing health.Our pioneering
technology spans the world of healthcare operations - with medical
diagnostic instruments, tests, automation and informatics solutions
for hospitals, reference labs, blood centers, emergency
departments, physician offices and clinics.Our location in Irving,
TX currently has an opportunity for a Sr. Regulatory Affairs
Specialist .MAIN PURPOSE OF ROLEAs an individual contributor, the
function of a Senior Regulatory Affairs Specialist is to provide
support for the regulatory department to ensure efficient and
compliant business processes and environment. The individual may
execute tasks and play a consultative role by partnering across
business functions. The individual may assist in identifying data
needed, obtaining these data and ensuring that they are effectively
presented for the registration of products worldwide. The
individual may prepare and submit documentation needed for
registration worldwide or may oversee such preparation.WHAT YOU'LL
DO* Leverage MS Excel and project management tools to track and
provide team updates on progress against project deliverables.
Facilitate negotiations to what is aggressively achievable to
exceed Division timeline expectations.* Update Regulatory
Information System as information is acquired to support future
submissions.* Work with project team to develop key deliverables
that need to be tracked and managed. Manage detailed plans and
anticipate possible road blocks to meeting plan.* Regulatory Assess
hardware and software changes to determine impact on on-market
products. * Approve Global Service and Support Technical Service
Bulletins* Participate on cross-functional teams as the Subject
Matter Expert* Assess emerging Regulations against Quality System.
Perform a Regulatory Assessment and recommendation.Premarket:* Work
with project team to develop key deliverables that need to be
tracked and managed. Manage detailed plans and anticipate possible
road blocks to meeting plan.* Take ownership of the project and
develop effective working relationships and communication with team
members and business partners to develop plans to meet the
timelines, then follow up on those deliverables to hold self and
others accountable for commitments.* Work independently and with
team members to identify and then mitigate risks/issues.* Assess
the acceptability of quality, technical documentation for 510(k)
submissions and PMA 180-day Supplements* Compile, prepare, review
and submit regulatory submission to authorities* Monitor impact of
changing regulations on submission strategies* Monitor applications
under regulatory review* Monitor and submit applicable reports to
regulatory authorities* Evaluate proposed Engineering manufacturing
changes for regulatory filing strategies* Negotiate and interact
with regulatory authorities during the development and review
process to ensure submission approvalPostmarket:* Maintain annual
licenses, registrations, and listings* Assist compliance with
product post-marketing approval requirements; Experience in CAPA*
Review and approve advertising and promotional items to ensure
regulatory compliance* Assess external communications relative to
regulations* Review regulatory aspects of contracts* Assist with
label development and review for compliance before release* Submit
and review change controls to determine the level of change and
consequent submission requirements* Analyze the input of cumulative
product changes to current product submissions* Ensure product
safety issues and product-associated events are reported to
regulatory agencies* Provide regulatory input for product recalls
and recall communicationsEDUCATION AND EXPERIENCE YOU'LL
BRINGRequired* Bachelor's Degree (or equivalent); Bachelor's Degree
in science (biology, chemistry, microbiology, immunology, medical
technology, pharmacy, pharmacology), math, engineering, or medical
fields is preferred. Certification is a plus (such as RAC from the
Regulatory Affairs Professionals Society.) * 2-3 years of
experience in regulatory preferred but may consider quality
assurance, research and development/support, scientific affairs,
operations, or related area. * 3-4 years' experience in a regulated
industry (e.g., medical products, nutritionals). * MDSAP knowledge
a plus. ISO13485, IEC61010, ISO 9001 knowledge. * Change control,
Engineering Controls, Risk Management Preferred* Bachelor's Degree
in Engineering (e.g. Mechanical, Electrical, or similar), highly
preferred.* 3 (+) years' above Regulatory work experience from
medical device industry or similar industry.WHAT WE OFFER At
Abbott, you can have a good job that can grow into a great career.
We offer:* Training and career development, with onboarding
programs for new employees and tuition assistance* Financial
security through competitive compensation, incentives and
retirement plans* Health care and well-being programs including
medical, dental, vision, wellness and occupational health programs*
Paid time off* 401(k) retirement savings with a generous company
match* Pension Plan* The stability of a company with a record of
strong financial performance and history of being actively involved
in local communitiesLearn more about our benefits that add real
value to your life to help you live fully:
www.abbottbenefits.comFollow your career aspirations to Abbott for
diverse opportunities with a company that provides the growth and
strength to build your future. Abbott is an Equal Opportunity
Employer, committed to employee diversity.Connect with us at
www.abbott.com, on Facebook at www.facebook.com/Abbott and on
Twitter @AbbottNews and @AbbottGlobal.
Keywords: Abbott Laboratories, Irving , Sr. Regulatory Affairs Specialist - Medical Device, Other , Irving, Texas
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