Regulatory Affairs Manager - Greer, Sc

Regulatory Affairs Manager - Greer, SCPosition Summary

Reporting to the Director of Quality, the Regulatory Affairs Manager is responsible for ensuring that products for which Alltrista Plastics has design responsibility comply with relevant government statutory and regulatory requirements, that patient safety and product efficacy are at the forefront of business activities and additional customer requested information. This individual acts as the critical liaison among Alltrista, Alltrista’s medical device customers, and regulatory authorities. The position will also establish and manage a supplier approval program.

 Primary Functions – Regulatory

• Ensuring the health and safety of all employees and diligently adhering to all safety rules and regulations.
• Has a broad understanding of medical packaging and medical device statutory, regulatory, and consensus standard requirements. Knowledgeable about FDA, Health Canada, and EU requirements, completing dossier for Drug Master File, 21 CFR 177, and USP <660>, <661>, <670>, and <671> testing requirements.
• Provides regulatory expertise to quality managers, program managers, and senior management on new product development and existing product requirements. Stays up to date with the latest rules and regulations and keeps all quality location updated with changes.
• Manages current Drug Master File and preparation and submission of new regulatory documentation.
• Supports the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to Company regulatory information concerning current, pending, and future approvals and renewals.
• Ensures the cost of regulatory compliance is captured in new product introduction and charged back to customers if required.
• Assists in reviewing product and process documentation for assigned projects to ensure compliance with requirements and monitors renewals to strict deadlines. Manages annual DMF review and submission.
• Acts as liaison among multiple project teams to obtain significant information as well as to answer regulatory and supplier quality queries that may arise in a timely and efficient manner.
• Manages the Alltrista brand specification approval. Communicates changes to customers for design of existing products and company practices where necessary. Aids in the development of product trials and analytical and microbiological specifications. Interprets trial data and creates internal documents.
• Works with marketing for packaging or advertising approvals regarding use of FDA and ISO terminology.
• Research customer regulatory requests and prepare responses.

 

Secondary Functions – Supplier Quality Auditor

• Establishes a division level supplier quality program that aligns with Alltrista EcoVadis goals – Social Responsibility, Sustainability, Traceability, and Predictability.
• Plans and schedules audits and assesses the capabilities of suppliers. These audits and inspections can be conducted on-site or remotely.
• Outlines schedule in a manner to show cost of onsite audits to ensure cost is budgeted for the following year.