QM & Regulatory Affairs Specialist

2 months ago


Elmsford, United States Herbstreith & Fox Full time

We are currently seeking a QM & Regulatory Affairs Specialist to oversee and manage quality management (QM) topics while addressing regulatory questions. In this role, you will support the sales team and business development by addressing QM and regulatory inquiries from our customers. Additionally, you will develop and implement programs and processes that ensure the highest standards in quality, regulatory compliance, and food safety for our U.S. operations. You will work closely with the onsite management team and collaborate with the QM team at our headquarters. The QM & Regulatory Affairs Specialist reports directly to the Director of Sales & Business Development.Key Responsibilities:Design and Review: Develop, review, and update quality standards, procedures, and specifications to align with current guidelines. Research and implement international regulatory standards.Documentation Management: Create and maintain QM documentation, ensuring accuracy and compliance with regulatory requirements.Regulatory Support: Provide expert regulatory support to both internal teams and external customers. Address inquiries related to QM and regulatory matters from customers and prospects.Policy Development: Develop and implement document management policies and procedures to streamline operations and ensure compliance.Cross-Functional Collaboration: Work with cross-functional teams to ensure products meet all necessary regulatory requirements.Audits: Prepare for, conduct, and evaluate internal and external audits, ensuring thorough compliance and continuous improvement.Incident Management: Process customer incidents and maintain internal control documentation to ensure transparency and accountability.Training & Education: Conduct training sessions and seminars on QM topics, hygiene, food safety, and food legislation to enhance team knowledge and compliance.Regulatory Strategy: Identify and address regulatory challenges related to commercial opportunities. Guide management on potential compliance risks and maintain the ethical integrity of the business.Regulatory Agency Interaction: Engage with regulatory agencies during audits, inspections, and ongoing communications to represent the company effectively.Qualifications:Educational Background: Degree in Food Technology, Chemistry, Nutrition, or a related field.Experience: 3-5 years of experience in technical support, food safety, or quality management.Industry Knowledge: Strong understanding of relevant regulations and standards in the food industry.Leadership & Communication: Excellent leadership, communication, and presentation skills.Detail-Oriented: Strong organizational and time management skills, with a keen attention to detail.Team Player: Ability to work independently and collaboratively within a team environment.Risk Management: Proficient in risk management and problem-solving.Technical Skills: Proficiency in MS Office Suite (Word, Excel, PowerPoint, etc.).



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