Regulatory Affairs Operations Specialist I

3 weeks ago

Saint Paul, Minnesota, United States Abbott Laboratories Full time

About Us

Abbott Laboratories is a leading global healthcare company dedicated to improving lives through innovative technologies, products and services. We are committed to helping people live more fully at all stages of life.

Our Mission

We strive to be a trusted partner for our customers, patients and employees by delivering high-quality products and services that make a meaningful difference in their lives.

The Opportunity

We are currently seeking a Regulatory Affairs Operations Specialist I to join our team in St. Paul, MN. This role will provide specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications.

Your Responsibilities

  • You will perform 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.
  • You will be responsible for following SOPs for managing GTS licenses, additional release authorizations (ARAs) and tender support and overall regulatory operations activities.
  • You will have a full working knowledge of GTS license types, country regulatory and language requirements.
  • You will provide support for Product and Country Experts in the set-up for release of new and modified products globally.
  • You will act as a regulatory representative responsible for review and analysis of GTS blocked orders, providing guidance and direction on regulatory compliance.
  • You will review and evaluate customer service requests and monitoring of email box for such requests, maintaining a high level of service and follow through on all communications.
  • You will ensure communications convey all necessary detail and adhere to applicable regulatory standards.
  • You will maintain positive and cooperative communications and collaboration with all levels of employees worldwide; customers, contractors, and vendors.
  • You will have a basic understanding of product lines being supported.
  • You will have full understanding of Windchill and SAP applications for research, problem solving and analysis of blocked orders and creation of GTS licenses.
  • You will represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, In-Country affiliates and IT.
  • You will support 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.
  • You will comply with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.
  • You will participate in projects affecting GTS licenses and performs other related duties and responsibilities, as assigned

What You'll Need

  • Bachelor's 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.

Salary Information

The estimated salary range for this position is $48,000-$96,000 per year, based on location and qualifications.

Benefits

At Abbott Laboratories, we offer a comprehensive benefits package that includes medical, dental, vision, 401(k) plan, paid time off, and more. We are committed to supporting our employees' health and well-being, both on and off the job.

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