Regulatory Affairs Specialist

3 days ago


Downers Grove, Illinois, United States Lifelancer Full time

Company Overview:

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Hearthside is a world-class contract manufacturer producing wholesome baked goods, snacks and packaged foods for many of the world's leading food companies. As one of the largest and fastest growing food co-manufacturing companies in the US, we are the proud owner and operator of over 35 facilities globally.

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About the Role:

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We are seeking a highly skilled Regulatory Affairs Analyst to join our team in Downers Grove, IL. As a key member of our quality team, you will be responsible for coordinating and ensuring all finished product specifications are populated, published and filed in an accurate and timely manner per project expectations.

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Job Description:

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The successful candidate will have 3-5 years experience in Data Entry, Technical Product Documentation and 1-3 years experience in Regulatory Affairs, R&D. You will possess strong knowledge of Good Manufacturing Practices (GMPs), Hazard Analysis Critical Control Points and be proficient in MS Office Suite and SAP.

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Key Responsibilities:

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  • ">
  • Reviewing, updating, coordinating, publishing and filing finished product specifications">
  • Supporting food safety and quality functions in enterprise wide systems that include but are not limited to: SAP, customer portals, TraceGains software and Product Vision">
  • Entering in all raw material data into Product Vision for further ingredient and nutritional work for Regulatory Specialists and Product Developers when needed">
  • Interacting with customers, suppliers, other functions to obtain, understand information and ensure compliance to regulations, customer requirements and Hearthside Food policies and procedures">
  • Quality representative and coordinator of finished product specification publishing, filing">
  • Utilizing quality strategy and priority to drive">
  • Coordinating resources from multiple functions and layers for information into specifications">
  • Ability to articulate project impact to organization">
  • Support regulatory team with any additional tasks, special projects and back up Regulatory Affairs Analyst and Specialist job duties from time to time">
  • Follow Good Manufacturing Practices (GMPs) at all times">
  • Comply with all safety, health and environmental regulations as prescribed by law">
  • Comply with all Company rules, regulations and policies">
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Competencies & Knowledge:

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You will bring excellent oral and written communication skills, strong self-confidence and strong will to drive change. You will also possess excellent problem solving skills and the ability to work with autonomy.

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Benefits:

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We offer a competitive salary range of $80,000 - $110,000 per year, depending on experience, and outstanding benefits package, including medical, dental, vision, 401(k) match and paid time off.

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Requirements:

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To be considered for this exciting opportunity, please submit your resume and cover letter with your application.

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Lifelancer Platform:

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This role is posted on Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT.



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