Product Surveillance Analyst I. (Dallas, TX)

| Dallas-Fort Worth, TX
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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 113,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Job Description

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 location in Plano, TX currently has an opportunity for a Product Surveillance Analyst I.

WHAT YOU'LL DO
  • Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
  • Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.
  • Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
  • Collect, compile, and document regulatory reportability decisions using event investigation and regulatory decision models.
  • Draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
  • Apply codes to events to facilitate product performance records.
  • Review coding and investigations with engineering, laboratory, and other internal staff.
  • Draft written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
  • Communications include determination/eligibility for warranty credit or unreimbursed medical payments.
  • Begins establishing and cultivating a network of internal resources to facilitate completion of tasks.
  • Individual influence is typically exerted at the peer level.
  • Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks.
  • May exercise authority within pre-established limits and approval.


EDUCATION AND EXPERIENCE YOU'LL BRING

Required
  • Bachelor's Degree in healthcare or sciences or equivalent combination of education and work experience.
  • Strong written and oral communication skills.
  • Excellent ability to multitask, prioritize and meet deadlines.
  • Work independently and in a team in a busy department, while managing multiple on going tasks and investigations.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Experience working in a broader enterprise/cross-division business units.
  • Ability to leverage and/or engage others to accomplish projects.


Preferred
  • Knowledge of global regulations for medical device reporting and medical terminology is a plus.


WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:
  • 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 communities


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 @AbbottGlobal.

JOB FAMILY:
Operations Quality

DIVISION:
NM Neuromodulation

LOCATION:
United States > Texas > Plano : 6901 Preston Road

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 5 % of the Time

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
More Information on Abbott
Abbott operates in the Healthtech industry. The company is located in Abbot Park, IL. Abbott was founded in 2022. It has 97838 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Disability Insurance, Dental Benefits, Vision Benefits, Health Insurance Benefits and Life Insurance. To see all 197 open jobs at Abbott, click here.
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