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job summary: International Regulatory & Documentation Specialist $80K-$84K / 5% Bonus Reports to Mgr, Regulatory Affairs Hybrid - 2 days a week onsite JOB SUMMARY The International Regulatory & Documentation Specialist is responsible for preparing, reviewing, and gathering regulatory documents necessary for international product registrations (new and existing, excluding US and Canada) and related regulatory affairs activities, including consulting with local (country specific) regulatory resources to ensure product and company compliance to applicable regulatory requirements. ESSENTIAL JOB FUNCTIONS 1. Acts as the point of contact for International distributors regulatory groups and international consultants to support regional registration requirements and addresses any present and future regulatory concerns and/or inquiries about the products and their ingredients. 2. Plans, coordinates, and prepares International regulatory submissions of various types, including, but not limited to, EU, Asia, Australia, and Latin America technical documentation, international dossiers and registration filings. 3. Communicates International registration requirements to Management, Quality, and the Product Development Team. 4. Monitors International regulatory activities (via International market specific consulting groups, distributors' regulatory groups, and other government communication vehicles) and proactively presents, advises, and executes internal programs associated with these activities. 5. Works closely with Research and Development, Purchasing, Quality Assurance, and Quality Control to obtain all documents and test data necessary to comply with the regulations in International markets such as product safety, purity, efficacy, and claims substantiation requirements. 6. Coordinates timely preparation of requests for Certificates to Foreign Governments, Certificates of Pharmaceutical Product, Certificates of Manufacture and Free Sale. Interfaces with applicable regulatory agencies and international consulates. 7. Communicates product changes to International distributors' regulatory groups to properly assess proposed change implications and impact based on local regulations. 8. Communicates to management and internal customers (International Marketing, International Operations, R&D, and Quality) product change assessments per International markets. 9. Coordinates and assembles technical information necessary to the individual International markets to implement product changes as requested in the product change assessments. 10. Assembles product technical information necessary to the EU Safety Assessor to perform Product Safety Assessments. Coordinates all associated activities to obtain a Product Safety Assessment. 11. When necessary, reviews and evaluates product labeling to ensure compliance with the International market regulations and requirements. 12. Maintains contracts with International market specific consulting groups. 13. Prepares and manages EU dossiers to support product registrations of EU products. 14. Acts as the principal department contact for handling, planning, and responding to International regulatory inquiries and requests. 15. Master the ability of reading, reviewing and auditing documents and following procedures. Proficient at understanding the importance and the elements of a good change control process. 16. Proficiently understand the elements of a Product Master File and manage its lifecycle. 17. Working knowledge of US FDA OTC monographs and the cGMP compliance requirements for the Company's products. 18. Proficient at preparing and compiling product registration documents and dossiers. 19. Master the understanding of technical requirements for all quality and regulatory documentation supporting batch production documents and their lifecycle. 20. SME for the understanding of the cGMP requirements associated with the production and Quality lifecycle of an OTC drug. 21. Ability to understand and interpret product regulatory requirements from FDA OTC monographs, US Pharmacopeia and/or others, local, state, federal and international regulatory agencies. 22. Master the ability to monitor regulatory activities (via searches of government internet web sites, review of USP supplements, Federal Register publications, and other government communication vehicles) and understand their impact to the Company. Demonstrate the ability to proactively present, advise, and execute internal programs associated with these activities.   location: Oak Brook, Illinois job type: Permanent salary: $80,000 - 84,000 per year work hours: 8 to 4 education: Bachelors   responsibilities: ADDITIONAL RESPONSIBILITIES 1. Periodically audits International product packaging and labeling for adherence to International labeling regulations. 2. Periodically monitors International distributors' websites and social media for adherence to Standards. 3. Develops and implements creative regulatory strategies, approval schedules, and submission standards to achieve department and organization objectives. 4. Develops and maintains departmental procedures (SOP's) for international product registrations and activities. 5. Participates in facility audits and on issue-specific committees, as required by the Supervisor, Regulatory Affairs. 6. Performs and assumes other duties and responsibilities, as may be required by the Supervisor, Regulatory Affairs. 7. Supports the Winner's Circle and Quality System processes. 8. Master the understanding of the organization QMS and efficiently and thoroughly manage the product and raw materials master files documentation lifecycle. 9. Understand all the elements necessary for a product registration and their necessary steps. 10. Master the understanding of the Company Stability program and its impact on product lifecycle. 11. Ability to keep up with ever changing global compliance stability requirements (ICH) and effectively assess their impact on the Company's program. 12. Master the ability to handle multiple projects in logical sequence; Master the ability to plan, organize, and complete projects independently; Master keeping projects on target and on time with little to no delays.   qualifications: REQUIRED EDUCATION, EXPERIENCE AND SKILLS 1. Bachelor's degree in Chemistry, Biology, or related scientific discipline with 3-5 years of applicable Quality Assurance environment experience, preferably in the cosmetics/pharmaceutical OTC industry or 1-2 years of applicable Regulatory Affairs experience in the cosmetics/pharmaceutical OTC industry 2. Attention to detail and ability to work well under pressure. 3. Master's degree in Regulatory/Quality, or related scientific discipline with 1-3 years of applicable Quality Assurance environment experience, preferably in the cosmetics/pharmaceutical OTC industry or 1-2 years of applicable Regulatory Affairs experience in the cosmetics/pharmaceutical OTC industry. 4. Demonstrates high standards of ethics and compliance. Creates culture of mutual trust and understanding. 5. Effective interpersonal skills to interact with various levels of internal and external customers. 6. Proficient at effective communication skills (both written and oral) for interactions with Quality colleagues, project managers, and colleagues from numerous functional areas. 7. Good oral and written communication skills in business English (spelling, grammar, and punctuation). 8. Computer literacy in a Windows environment (Word, Excel, and Outlook). 9. Ability to prepare detailed and accurate documentation. 10. Able to present complicated compliance issues in a variety of business settings. 11. Familiarity with FDA regulations and monograph system as they relate to OTC drug products. 12. Working knowledge of Current Good Manufacturing Practices (cGMP). 13. Strong organizational and analytical abilities. 14. Ability to work independently and meet deadlines on a multitude of concurrent tasks. 15. Willingness to accept other duties, as assigned. 16. Discretion with confidential information. 17. Proficient at listening actively and readily assumes responsibility for actions and leads by example. 18. Proficient at managing tactical steps to push tasks forward. 19. Ability to develop and maintain an effective working relationship with internal and external customers, function as a team player, accept constructive criticism from management, and comply with Company policies. PHYSICAL DEMANDS & ENVIRONMENT 1. This position requires the individual to Stand, Walk, use hands to finger, handle or feel, climb or balance, stoop, kneel, bend or crawl, reach with hands and arms overhead up to 33% of the time. This position requires the individual to Sit, Talk or Listen 66 to 100% of the time. 2. This position will require the individual to lift up to 25 pounds 33 to 66% of the time. 3. The vision requirements for this position includes Close Vision (clear vision at 20 inches or less), Distance Vision (clear vision of 20 feet or more), Color Vision (ability to identify and distinguish colors), Peripheral Vision (ability to see up, down, left or right while eyes are fixed on a given point), Depth Perception (3-dimensional vision, ability to judge distances and spatial relationships), and Ability to Adjust Focus (ability to adjust the eye to bring an object into sharp focus). 4. The noise level for this position will be Moderate Noise (Ex: Business office with typewriters and/or computer printers, light foot traffic). 5. The Personal Protective Equipment requirements that are used in this position is a hair net, beard net and safety glasses   skills: Regulatory Affairs Operations Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

job summary: A prominent Capital Equipment Manufacturing company in the packaging industry is seeking a Supply Chain Manager for their facility in the Chicago area. They are looking for a Supply Chain Manager with 5+ years of procurement experience in capital equipment. This is a high priority search, and the role is salaried in the $120K+ range. This is an in office position- not hybrid or remote based.   location: ELK GROVE, Illinois job type: Permanent salary: $110,000 - 130,000 per year work hours: 8am to 4pm education: No Degree Required   responsibilities: ? Understand the list of items that are required for purchase from various sources (Purchase Request, Bill of Materials, Drawings, etc) and identify sourcing. ? Assist with Operations and Accounting to enable Job Cost Analysis and Financial Reporting. ? Support production schedules and obtain requirements (specs, required delivery date, etc) to enable economies of scale. ? Participate on weekly production meetings and periodic management meetings on procurement activities; report updates on purchase orders and status as required. ? Understand vendors in term of pricing, delivery and quality and set priority lists for each category as applicable. ? Manage and motivate the procurement and inventory team by providing direction and support for future growth and succession planning. ? Provide information and support as requested (materials, components, vendors). ? Identify and implements standardization opportunities and develop the procurement department with proper segregation of duties ? Develop and implement service level agreements with customers (engineering, production, service) ? Organize criteria for outsourcing vs in-house parts production with Production Manager and upper management. ? Supplier and Inventory Management   qualifications: Experience level: Education: No Degree Required  skills: Supply Chain Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

job summary: Our candidate is a Top 200 company looking for Design Engineer. Ideal candidate will have BS in Mechanical Engineering 5+ years of product design and development experience CAD Design/Modeling tools (preferred Pro/Engineer CREO-4).Finite Element Analysis, Statistics & Dynamics.Demonstrated design capability, problem solving skills and the ability to understand and troubleshoot electro-mechanical equipment.Experience in Matlab tools is a plus. Client offers fantastic benefits, starting bonus and great work-life balance!!   location: Lake Forest, Illinois job type: Permanent salary: $85,000 - 110,000 per year work hours: 8am to 5pm education: Bachelors   responsibilities: Provides technical leadership for product development teams and utilizes project management skills to define and manage resources and execute to achieve required outcomes. Collaborate with marketing, purchasing, manufacturing and other departments to construct project scope and determine costs and manufacturing feasibility. Initiate concept designs based on customer feedback, communicate those designs to other team members and develop those designs on 3D CAD. Utilize feedback from team members and external customers to adapt and improve product design to meet development objectives. Perform critical analysis on design (DFMEA, Design of Experiments). Communicate design requirements to other team members and evaluate designs to ensure project trajectory is consistent with product specifications. Responsible for all aspects of the design, layout (design integration), evaluation and documentation of electro-mechanical devices or system used on power fastening systems. Manage the production of prototypes, test units and subsequent manufacturing and testing to meet quality standards and planned schedules for delivery within target cost parameters. Recommend, implement and track performance of design modifications to eliminate product or system malfunctions. Select and implement appropriate manufacturing processes and vendors to ensure cost-effective, robust products that achieve market success. At this level, assignments can be complex and will require use of initiative and judgment. BS in Mechanical / Mechatronics Engineering (Master's Preferred). 5+ years of relevant product design and development experience required. CAD Design/Modeling tools (preferred Pro/Engineer CREO-4). Finite Element Analysis, Statistics & Dynamics. Demonstrated design capability, problem solving skills and the ability to understand and troubleshoot electro-mechanical equipment. Experience in Matlab/numerical computing tools is a plus. Exposure of project management and technical leadership is a plus. Domestic and International travel: 10-15%   qualifications: Experience level: ExperiencedMinimum 5 years of experienceEducation: Bachelors (required)  skills: Design Engineer (5 years of experience is required)Product Development (5 years of experience is required)CAD Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.