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Compliance Manager
Green Bay, WI

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STL Staffing

Product & Safety Compliance- 6 month project

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Job Description

Product & Safety Compliance- 6 month project STL Staffing - 3.3 Green Bay, WI Job Details Temporary | Full-time $21 - $23 an hour 1 day ago Qualifications Teamwork Analysis skills Attention to detail Data analytics Chemistry, manufacturing & controls Full Job Description Job Overview We are seeking a highly motivated and detail-oriented Product & Safety Compliance Specialist for a dynamic 6-month project. This role offers an exciting opportunity to lead critical compliance initiatives within the food sectors, ensuring adherence to rigorous regulatory standards. You will play a pivotal role in managing regulatory compliance activities, supporting safety protocols, and facilitating seamless communication across cross-functional teams. Your expertise will help uphold the highest quality standards, contributing to the successful development and commercialization of innovative healthcare products. This position is ideal for professionals passionate about regulatory affairs, quality assurance, and health regulation policies who thrive in fast-paced, collaborative environments. Duties Lead and coordinate regulatory compliance management efforts for product safety and quality assurance projects aligned with FDA regulations, EMA regulations, ISO 13485, and ICH guidelines. Prepare and review regulatory submissions, including FDA submissions, ensuring accuracy and completeness in accordance with drug regulation standards. Conduct comprehensive regulatory compliance analysis by evaluating clinical trial data, chemistry, manufacturing & controls (CMC), and biomedical regulatory compliance documentation. Support risk management activities by identifying potential compliance issues and developing mitigation strategies to ensure ongoing adherence to health regulation policies. Collaborate with cross-functional teams—including research, manufacturing, quality assurance, and legal—to facilitate regulatory compliance projects and ensure alignment with global standards. Utilize compliance management software to track project milestones, document findings, and maintain detailed records of all regulatory activities. Stay current on evolving regulations such as ICH guidelines, EMA regulations, FDA regulations, and other relevant health policies to advise internal teams accordingly. Experience Proven experience in food manufacturing regulatory compliance management or biomedical regulatory affairs within a regulated environment. Strong understanding of FDA regulations, drug regulation processes, clinical trials oversight, and health regulation policy frameworks. Demonstrated ability to manage regulatory submissions efficiently while ensuring compliance with
ISO 13485
standards for medical devices or similar quality standards. Expertise in conducting regulatory compliance analysis using data analysis skills to interpret complex information related to product safety and quality. Familiarity with risk management principles applied within the context of pharmaceutical or biomedical products. Excellent writing skills for preparing clear documentation such as technical reports, regulatory dossiers, and compliance reports. Effective cross-functional communication skills to coordinate activities across diverse teams involved in research, development, manufacturing, and quality assurance. Join us in this impactful role where your expertise will directly influence the safety and efficacy of healthcare products worldwide! We are committed to fostering an inclusive environment that supports your professional growth while ensuring the highest standards of regulatory compliance are met at every step.
Pay:
$21.00 - $23.00 per hour Expected hours: 40.0 per week
Work Location:
In person