Regulatory Affairs Specialist II
Company: Abbott Laboratories
Posted on: June 13, 2021
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 109,000 colleagues
serve people in more than 160 countries.
Our Neuromodulation business is an area of expertise for Abbott.
This business includes implantable devices compatible with mobile
technology to help people who suffer from chronic pain and movement
disorders. Our Solutions include Proclaim (TM) XR SCS System, the
#1 Spinal cord stimulator on the market, Proclaim (TM) DRG
Neurostimulator, the only FDA approved DRG therapy and a market
leader in radiofrequency ablation therapy, Abbott RFA. These
non-opioid therapies allow us to provide interventional pain
therapy to patients throughout the pain continuum. Our deep brain
stimulation technology for progressive diseases help people manage
their Parkinson's disease and essential tremor symptoms, steering
away from side effects.
Our site in Sylmar, CA or Plano, TX is looking for a Regulatory
Specialist II. This position performs specialized level work
assignments and/or analyses, evaluation, preparation, and
submission of documentation for the worldwide regulatory
registration, ensuring products and procedures comply with
regulatory agency specifications. Supports necessary regulatory
activities required for product market entry.
What You'll Do:
- Prepares robust regulatory applications (either for FDA or for
international regulatory agencies) to achieve departmental and
- Conducts reviews of product and manufacturing changes for
compliance with applicable regulations.
- Acts as a regulatory representative on core product development
teams, communicates regulatory requirements and impact of
regulations to the development team. Provides guidance and
- Reviews and evaluates communications to ensure communications
convey all necessary detail and adhere to applicable regulatory
standards including those set by the FDA or other worldwide
regulatory agencies to various international affiliates.
- Maintains pertinent domestic and international medical device
regulations to ensure submission requirements world-wide are
current, up-to-date and are entered into regulatory submission data
base and file systems. Ensures that information of such regulations
and requirements, especially those that are new or modified, are
distributed to appropriate personnel.
- May interface directly with FDA and other regulatory
- Work with cross-functional team to support product release
- Reviews protocols and reports to support regulatory
- Support all Company initiatives as identified by management and
in support of Quality Management Systems (QMS), Environmental
Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) and
international regulations, other regulatory requirements, Company
policies, operating procedures, processes, and task
- Maintains positive and cooperative communications and
collaboration with all levels of employees, customers, contractors,
- Performs other related duties and responsibilities, on
occasion, as assigned
Experience and Education You'll Bring:
- BA or BS degree; technical discipline preferred.
- Minimum 3 years of experience, including a minimum of two years
- Experience with either 510(k) applications, PMA supplements and
US device regulations or with EU and other international medical
device regulations and submissions.
- Experience working in a broader enterprise/cross-division
business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse
- Ability to work within a team and as an individual contributor
in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish
- Strong verbal and written communications with ability to
effectively communicate at multiple levels in the
- Multitasks, prioritizes and meets deadlines in timely
- Strong organizational and follow-up skills, as well as
attention to detail.
- Ability to travel approximately 5%, including
- Ability to maintain regular and predictable attendance
- A fast-paced work environment where your safety is our priority
(Include for Manufacturing roles only)
- Production areas that are clean, well-lit and
temperature-controlled (Include for Manufacturing roles only)
- 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
- The stability of a company with a record of strong financial
performance and history of being actively involved in local
Learn more about our benefits that add real value to your life
to help you live fully: www.abbottbenefits.com
Follow 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
Keywords: Abbott Laboratories, Plano , Regulatory Affairs Specialist II, Other , Plano, Texas
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