Regulatory Affairs Specialist I – Ventures (on-site)

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: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve peoples health. Were always looking towards the future, anticipating changes in medical science and technology. 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. Structural Heart Business Mission: why we exist Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. The Opportunity We are recruiting for a Regulatory Affairs Specialist I to join our team on-site in Santa Clara, CA or St. Paul, MN. 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 registration worldwide. What Youll Work On Analyzes the input of cumulative product changes to current product submissions. Shares knowledge with others in department and on teams. Provides solutions to a variety of problems where analysis requires moderate degree of evaluation. Prepares and aligns individual goals with department goals. Establishes and executes against project goals and implements plans. Provides input to establishing group plans and implementation of those plans. Follows GMP guidelines and procedures. Writes Effectively: Prepares written information in a clear and concise fashion, appropriately designed for varying target audiences. Responsible for implementing and maintaining the effectiveness of the quality system. For products division-wide: Advises and communicates to project, group, or venture regarding basic regulatory strategies. Signs-off at team level within delegated parameters for change control. Release authority for labeling/sales/promotional materials. Official correspondence with outside regulatory agencies are guided by supervisory staff. Conducts basic negotiations on routine product related issues with government agencies. Follows through on submission related activities to secure product approval. Directs own daily activities by utilizing team goals and division regulatory priorities. Provides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system. Obtains supervisory regulatory review on submission documents prior to submission to government agencies. Required Qualifications Bachelors degree or equivalent combination of education and work experience Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Ability to work in a highly matrixed and geographically diverse business environment. Ability to leverage and/or engage others to accomplish projects. 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. Some experience with medical device industry Experience working in a broader enterprise/cross-division business unit model. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com 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.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. The base pay for this position is $50,000.00 $100,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: SH Structural Heart LOCATION: United States > Minnesota> St. Paul > Woodridge : 177 East County Rd B ADDITIONAL LOCATIONS: United States > Santa Clara : Building A - SC WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) 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