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International Regulatory Specialist - Latin America

Medline Industries, Inc. has an immediate opening for an International Regulatory Affairs Specialist €“ Latin America based in Northfield, IL. This position will focus on international regulatory affairs as it relates to medical device product development and various international submissions, research, review, medical device manufacturing, and regulatory aspects of vendor management. We are seeking a dynamic, hardworking professional with a solid education and background in Latin American Regulatory Affairs and a desire to work for a fast-paced, large corporate organization. Targets include Argentina, Brazil, Chile, Colombia, Ecuador, Guatemala, Panama, Uruguay, and other potential markets. In addition to exceptional leadership and analytical skills, you must have a "roll-up your sleeves" attitude.
The International Regulatory Affairs Specialist will be responsible for:
Leading International Regulatory Affairs activities specific to the Latin American regions.
Support of new product development teams and the preparation and submission of regulatory documentation for product registration/licensing in selected markets.
Prepare and approve regulatory files as part of the International Regulatory Affairs team to obtain product registration approvals in regional markets
Assisting with the maintenance of regulatory files to ensure prompt and accurate access to regulatory information.
Complete and maintain Medline or vendor product licenses, registrations or listings as required, interacting with state, federal or international regulatory authorities and internal customers to accomplish.
Determine the requirements for and complete Medline product submissions for regulatory authority clearance or approval (to market a new product as a drug, medical device, food, dietary supplement, biological, cosmetic or commodity item) by working with vendors, internal customers and consultants as needed.
Communicate requirements of regulations to internal or external customers, or to vendors.
Maintain department databases, logs and files.
Medline offers a business casual, entrepreneurial work environment with strong growth potential, a competitive compensation package, and a complete benefits package including medical/dental/vision/life insurance; 401(k) with company match. And much more!
Requirements include:
Bachelor's Degree (biology, chemistry, engineering, information technology, pharmacology, quality, toxicology, clinical sciences) AND at least 2 years of experience in regulatory, quality assurance, research and development/support, scientific affairs, operations, or related area preferred OR High school diploma or equivalent AND at least 5 years of experience in regulatory, quality assurance, research and development/support, scientific affairs, operations, or related area.
Experience applying an understanding of the current Regulatory environment and demonstrating the ability to perform within.
Experience applying knowledge of FDA regulations and guidelines on advertising and promotional drug products.
Experience evaluating information to determine compliance with standards, laws, and regulations.
Advanced skill level in SAP and AS400. Advanced skill level in Excel, Word.
Preferred requirements include:
At least 1 year of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Experience in creating dossiers and maintaining international registrations for devices, drugs and cosmetics.
Experience internationally with both prescription and retail product registrations
Experience preparing and filing complete A/NDA's, Supplements, Amendments and Annual Reports to FDA.
Experience applying knowledge of the CFR, FDA/ICH guidelines and cGMP's as they pertain to pharmaceuticals.
Experience applying knowledge of FDA regulations and guidelines on advertising and promotional drug products.
Bilingual English-Spanish reading, writing, and verbal skills preferred.

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