ABBOTT LABORATORIES Regulatory Affairs Operations Specialist I Salary in the United States

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 103,000 colleagues serve people in more than 160 countries.

Regulatory Affairs Operations Specialist I
 

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.    

Impact this role will have on Abbott:

• 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 worldwide; 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  

Your experience(s), education and knowledge will further expand Abbott’s marketplace success:

• BA or BS degree required.
• 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.
• Process oriented.  

Your preferred qualifications and education:

• Medical device or other medical experience background.