Regulatory Compliance Associate

General Summary:

The Regulatory Compliance Associate is responsible for learning and implementing company policies and works to ensure Zeus meets all state, local, federal, international, and industry specific regulations that apply to our products. This role will also oversee regulatory requirements related to new material qualification and validation to support any applicable regulatory requirements.

Principal Duties and Responsibilities:

• Assists with tracking and retrieval of information pertinent to the regulatory process, including coordinating and preparing US and International regulatory documents
• Coordinates and completes reports required in support of customers and governing bodies by maintaining an electronic document management system and working with project teams to obtain approval for company products
• Liaisons with Sales and Quality for raw material and regulatory requirements
• Provides regulatory support for current products and input for development projects
• Stays up-to-date on regulatory guidance documents, regulations, and technical/scientific developments that may impact commercial and development projects.
• Provides evaluation regarding the impact of regulatory guidance documents and regulations that impact company products and operations

• Assists in the development and update of regulatory strategy and SOPs
• Evaluates regulatory impact of proposed changes to launched products

• Reviews product claims and preserves confidentiality of applicable product information
• Provides regulatory input for and appropriate follow-up to inspections and audits
• Additional responsibilities as needed

Knowledge, Skills, and Abilities Required

• Bachelor degree (preferably a BS)
• Hands-on experience in Regulatory Affairs, or relevant practical training in the field is preferred.
• Excellent analytical skills and the ability to apply policies and general regulations to specific products or projects.
• Good verbal and written communication and interpersonal skills
• Ability to work effectively on project teams as well as individually
• Knowledge and understanding of scientific and regulatory terminology

• Working knowledge of Microsoft Office, specifically Excel and Word.
• Strong organizational skills and the ability to handle multiple tasks independently.
• Ability to carry out oral and written instructions
• Detail oriented - able to review and understand written communications
• Excellent time management skills

Disclaimer Statement: Job description is not intended to be an exhaustive list of all job duties and/or knowledge, skills, and abilities required, but a description of the job's most important elements. Nothing in this description restricts management's right to assign or reassign duties and responsibilities to this job at any time.