Regulatory Affairs Specialist

1 week ago

Saint Paul, Minnesota, United States Abbott Full time

The Opportunity

We are seeking a highly skilled Regulatory Affairs Operations Specialist to join our team at Abbott. This role will be responsible for performing 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.

Key Responsibilities

  • Support the preparation of Global Trade Services (GTS) licenses for products, countries, and business partners, ensuring timely shipment and departmental objectives.
  • Manage GTS licenses, additional release authorizations (ARAs), and tender support, adhering to SOPs and regulatory operations activities.
  • Develop a thorough understanding of GTS license types, country regulatory, and language requirements.
  • Collaborate with Product and Country Experts to set up releases for new and modified products globally.
  • Act as a regulatory representative, reviewing and analyzing GTS blocked orders, providing guidance and direction on regulatory compliance.
  • Monitor customer service requests and email communications, maintaining a high level of service and follow-through.
  • Ensure all communications convey necessary detail and adhere to applicable regulatory standards.
  • Maintain positive and cooperative communications with employees worldwide, customers, contractors, and vendors.
  • Develop a basic understanding of product lines being supported.
  • Utilize Windchill and SAP applications for research, problem-solving, and analysis of blocked orders and GTS license creation.
  • Represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, In-Country affiliates, and IT.
  • Support business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, international regulations, and other regulatory requirements, company policies, operating procedures, processes, and task assignments.

Requirements

  • Bachelor's Degree or 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 a timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.

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