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 114,000 colleagues serve people in more than 160 countries. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: + Career development with an international company where you can grow the career you dream of. + Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. + An excellent retirement savings plan with a high employer contribution. + Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree. + A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. + A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This position works out of our Plano, TX location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Under the direction of the Quality Team manager, the Specialist, Regulatory Reporting will support the PPG organization in administrating regulatory reporting activities pertaining to product complaints for the Neuromodulation Division of Abbott. Activities will focus on efficient handling of receiving and assessing worldwide complaints for potential medical reporting, assessing and responding to requests for information from global regulatory bodies, post market surveillance reporting, and contributing to monitoring the overall quality of complaint records of the PPG team. **WHAT YOU’LL DO** + Serve as a resource for the PPG team on regulatory reporting + Make and ensure accuracy of reportability decisions, following Good Documentation Practices (GDP) + Ensure complaints are reported to various global regulatory agencies (e.g., FDA, European Competent Authorities) within required timeframes + Analyze and respond to complaint related regulatory inquiries. Responsible for: + Serving as a project lead for the internal response team + Coordinating response efforts and preparation of draft communication for management review + Delivery of final communication to regulatory body + Support post market reporting activities + Serve as PPG point of contact for the post market surveillance team + Provide complaint reports supporting PSUR and CER activities + Support maintaining / enhancing overall quality of the complaints process by monitoring complaints records and providing coaching to file managers + Provide related training that is appropriate and maintained across the entire team + Communicate verbally and in writing, both internally and externally, Medical Events reporting decisions, Requests for Information (RFIs) and Post Market product performance analysis reports + Complies with U.S. Food and Drug Administration (FDA) regulations, other international regulatory requirements, Company policies, operating procedures, processes, and task assignments. + Performs other related duties and responsibilities, on occasion, as assigned. **Required Qualfiications** + BS Degree in nursing, biomedical engineering or other science discipline + 2+ years experience in Product Surveillance for medical products or healthcare + Demonstrated leadership and ability to lead a team in a fast paced changing environment + Strong written and oral communication skills + Good problem-solving skills and networking skills + Ability to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously. **Preferred Qualfiications** + Knowledge of global regulations for medical device reporting and medical terminology is a plus + Provides medical review of complaints for reportability decisions + Experience working in a broader enterprise/cross-division business unit model + Ability to work in a highly matrixed and geographically diverse business environment and leverage and/or engage others to accomplish projects Apply Now (https://www.jobs.abbott/us/en) **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx) Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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. The base pay for this position is $60,000.00 – $120,000.00. In specific locations, the pay range may vary from the range posted. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com