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 YOU’LL 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: 

• Bachelor’s 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.