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Documentation and Regulatory Coordinator

Manufacturing llc

Documentation and Regulatory Coordinator

Putnam, CT
Full Time
Paid
  • Responsibilities

    We have an exciting opportunity for an experienced Documentation and Regulatory Coordinator with a medical manufacturing company plays a pivotal role in ensuring materials compliance for our products. This position is responsible for maintaining a comprehensive understanding of and adherence to various materials regulatory requirements, such as Prop65, REACH, RoHS, TSCA, and Conflict Minerals. The Regulatory Coordinator will collaborate with internal teams, suppliers, and customers to guarantee that the organization meets all materials compliance standards for the products it sells.

    RESPONSIBILITIES include but are not limited to:

    Ensure organizational compliance with materials regulations, including Prop65, REACH, RoHS, TSCA, and Conflict Minerals.

    Stay informed about changes to regulatory requirements and recommend actions to maintain compliance.:

    Maintain a comprehensive database of materials for both purchased and manufactured goods.

    Manage supplier compliance declarations and communicate with suppliers regarding material compliance.

    Assist product development and support engineers in ensuring new and existing products comply with regulatory standards.

    Propose and implement changes in the production environment to align with regulatory requirements.

    Respond to customer compliance requests promptly and effectively.

    Ensure compliance requirements are met for product labeling, packaging artwork, and instruction booklets.

    Effectively plan and prioritize activities to meet regulatory deadlines.

    Demonstrate strong communication skills, both written and verbal, with the ability to interact effectively with internal and external stakeholders.

    Interface with cross-functional teams, customers, and suppliers to address compliance-related matters.

    Possess good analytical skills and the ability to work independently to solve complex problems.

    SCOPE:

    Solve complex problems, taking a new perspective using existing solutions.

    Work independently with minimal guidance.

    Act as a resource for colleagues with less experience.

    SKILLS/REQUIREMENTS:

    Minimum of 3 years of experience in materials compliance or a related role.

    BA/BS degree.

    Proficiency in Microsoft Office Suite.

    Experience with industry standard materials compliance software is preferred.

    This position is crucial in maintaining the integrity of our products in the market while ensuring adherence to all relevant materials compliance regulations. The Regulatory Coordinator will contribute to the success of the organization by proactively managing materials compliance and fostering effective communication across various stakeholders. APPLY TODAY for immediate consideration!

    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.