Regulatory Affairs Specialist I

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. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youll 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 high employer contribution · Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree. · A company recognized as a great place to work in dozens of countries around the world 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 a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity We are recruiting for a Regulatory Affairs Specialist I to join our team on-site in Sylmar, CA or Scottsdale, AZ. As an individual contributor, the function of a Regulatory Affairs Specialist I is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for US and international registration assessments. What Youll Work On Annual Reports FDA APRs, ARCs (support), Custom Devices, Ics (support). Tracking of annual FDA PMA payments. FDA Establishment Registrations for CRM Sites (3). Includes all FURLS DL maintenance and annual verification. Export Documentation CFG, COE, Notifications UDI Support FDA and EU Management of EU and AU Declarations of Conformity (DoCs) Submission and Approved Product Tracking and Reporting US, EU, AU and CA TUV Appendix ABC Information Tracking and updates EU product information including key processes, facilities and supplier information Certificate Management Windchill, SAP and Informatica key systems CRM Regulatory CO capabilities to update documents Audit support providing Regulatory information for CRM related audits and performing back room support Product Rationalization US, EU, CA notifications of discontinuances and shortages, FURLS, GUDID and EUDAMED updates for discontinued products. General support as needed. Support key submissions when requested Required Qualifications · Bachelors Degree or an equivalent combination of education and work experience Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. 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 projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Preferred Qualifications · Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields. · Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) · Think analytically with good problem-solving skills. · Strong attention to detail and organization skills. · Self-driven to perform tasks such as researching regulatory requirements and locating information. The base pay for this position is $72,100.00 $114,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: CRM Cardiac Rhythm Management LOCATION: United States > Sylmar : 15900 Valley View Court ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No 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 Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter