Abbott Regulatory Affairs Operations Specialist I in St. Paul, Minnesota
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
We are seeking an experienced, high caliber Regulatory Affairs Specialist I to perform specialized level work assignments and/or analyses, evaluation, preparation, and management of global regulatory product releases and general support of global regulatory activities. Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals
Daily support of product releases by preparing Global Trade Services (GTS) licenses for products, countries and business partners allowing shipment of product to achieve departmental and organizational objectives
Responsible for following SOPs for managing GTS licenses, additional release authorizations (ARAs) and tender support and overall regulatory operations activities
Have a full working knowledge of GTS license types, country regulatory and language requirements - Provide support for Product and Country Experts in the set-up for release of new and modified products globally
Acts as a regulatory representative responsible for review and analysis of GTS blocked orders, providing guidance and direction on regulatory compliance
Reviews and evaluates customer service requests and monitoring of 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 world-wide; customers, contractors, and vendors
Have a basic understanding of product lines being supported - Have full understanding of Windchill and SAP applications for research, problem solving and analysis of blocked orders and creation of GTS licenses
Represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, In-Country affiliates and IT
Support and submission of CFGs (Certificates to Foreign Governments), CECATS (CDRH Export Certification Application and Tracking System), COEs (Certificates of Export) and Free Sales Certificates (FSCs) - 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 GTS licenses and performs other related duties and responsibilities, as assigned
Required experience(s), education and knowledge will further expand Abbott’s marketplace success:
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 - Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Multitasks, prioritizes and meets deadlines in timely manner
Ability to collaborate and work cross functionally
Strong organizational and follow-up skills, as well as attention to detail
Ability to maintain regular and predictable attendance
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
ASJM Abbott St. Jude Medical
United States > Minnesota : One St Jude Medical Drive
SIGNIFICANT WORK ACTIVITIES:
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 125 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 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s 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 life’s 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.
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