Regulatory Affairs Operations Specialist I
2 months ago
The Opportunity
We are currently hiring a Regulatory Affairs Operations Specialist I to work on-site at our St. Paul, MN location. This new team member will perform 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. Additionally, will support necessary regulatory activities required for product market entry.
What You’ll Work On
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. 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 assignedRequired Qualifications
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.Preferred Qualifications
Bachelor’s Degree in a technical discipline. Experience with medical device industry. Experience working in a broader enterprise/cross-division business unit model. 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.*
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