Regulatory Operations Specialist II

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. 

• 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.