Regulatory Operations Specialist II

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: Job Description WHAT YOULL DO We are recruiting for a Regulatory Operations Specialist II, to join our team in the Plymouth, MN location. In this role, you will be responsible for specialized level work assignments and/or analyses, evaluation, preparation, and management of global regulatory product releases and general support of global regulatory activities. Responsibilities: 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. 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. Represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, In-Country affiliates 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, 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 Qualifications: Bachelors Degree In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience Masters Degree (± 18 years), Preferred Minimum 2 years, This position does not require previous regulatory experience. 2-3 years experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Experience with Regulatory history, guidelines, policies, standards,practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Submission/registration types and requirements; GxPs (GCPs, GLPs, GMPs); Principles and requirements of promotion, advertising and labeling; Domestic and regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note: This knowledge may be developed through tenure in this position. Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents. Work with cross-functional teams. Work with people from various disciplines and cultures. Write and edit technical documents. Negotiate internally. Pay strong attention to detail. Manage projects. Create project plans and timelines. Think analytically and critically. Organize and track complex information. Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of a variety of alternatives and their impact on the business. Apply business and regulatory ethical standards. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Preferred Qualificaitons: BA or BS degree in communications, regulatory, business, engineering or equivalent combination of education and work experience. 2-4 years work experience in a regulated environment Ability to manage projects and drive them to completion with attention to detail. Requires ability to be innovative, resourceful, and work with minimal direction. Strong written and verbal communication, at all organizational levels. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Experience working in medical device industry with focuses on regulatory, or quality systems preferred. Experience working with ERP and/or PLM systems preferred. Preferably SAP and/or Windchill. Strong problem solving skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy. Skilled in Microsoft Office specifically Excel, PowerPoint, and Word. The base pay for this position is $60,000.00 $120,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: EP Electrophysiology LOCATION: United States > Minnesota > Plymouth : 5050 Nathan Lane N 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