Regulatory Operations 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. · 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. · Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year · 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. For years, Abbotts medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether its glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ngersticks. The Opportunity We are currently hiring a Regulatory Affairs Operations Specialist I to work on-site at our St. Paul or Maple Grove, MN location. This new team member will perform specialized level work assignments and/or analyses, supporting necessary regulatory activities required for product market entry. What Youll Work On · Daily support of product release by preparing licensing for products, countries and business partners allowing shipment of product to achieve departmental and organizational objectives. · Responsible for following SOPs, product market launches, licensing accuracy, clinical and distribution, supply planning support and overall regulatory operations activities. · Have a full working knowledge of product release and licensing types, country regulatory and language requirements. · Provide support for Regulatory Affairs in the set-up for new approvals, renewals and release of products globally. · Acts as a regulatory representative responsible for review and analysis of blocked sales and distribution orders, providing guidance and direction on regulatory compliance. · Reviews and evaluates customer service requests and monitoring of shared email box for such requests, maintaining a high level of service and follow through on all communications. · Ensure communications convey all necessary detail and adhere to applicable regulatory standards. · Maintains positive and cooperative communications and collaboration with all levels of employees worldwide; customers, contractors, and vendors. · Have a basic understanding of product lines being supported. · Have full understanding of systems and applications for research, problem solving and analysis of blocked orders and creation of product licensing. Applications include Windchill and SAP. · Represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, Regulatory In-Country affiliates, US Regulatory partners and IT. · Supports all business segment initiatives as identified by divisional 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) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments. · Participates in projects affecting product release and performs other related duties and responsibilities, as assigned Required Qualifications · Bachelors Degree OR an equivalent combination of education or work experience. · 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 a technical discipline. · Experience with medical device industry. · Experience working in a broader enterprise/cross-division business unit model. · Strong problem solving skills and ability to think strategically and see the big picture. · Adaptable with the ability to switch priorities and accomplish all tasks. · Process oriented. 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: MD Medical Devices LOCATION: United States > Minnesota > St. Paul > Lillehei : One Lillehei Plaza 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