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Regulatory Affairs Manager

4 months ago

Greer, United States Human Resources Full time

Alltrista Plastics LLC, is a subsidiary of Jadex Inc., and is a leading manufacturer in high-volume, precision injection molded parts.The company designs and manufactures with proprietary engineering processes and extensive manufacturing capabilities, from five (5) locations worldwide. From the first spark of an idea, through the design of the mold to the actual manufactured product, Alltrista Plastics focuses all efforts on delivering innovative plastic solutions.The company’s core markets include Consumer Products, Medical/Healthcare, Personal Care, Health & Beauty, Caps & Closures, and Packaging. Regulatory Affairs Manager - Greer, SC

Position 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

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,

, and

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. Ensures that all non-conformances are documented in IQS and that corrective actions are taken and implemented on products or processes. Support Procurement resources to assistance supplier onboarding and cost reduction initiatives. Works with plant controllers to verify score card reviews are in place and being used as intended. Aids in ranking suppliers by rating their developmental processes and sending reviews to companies. Once program is established, reviews the quality costs of suppliers and provides feedback to both Director of Quality and Directory of Logistics. Key Qualifications

Certified Quality Auditor and Lead Auditor certification preferred. Minimum two to five years of experience in quality management, working in regulatory field with demonstrated successful performance. Familiarity with 21 CFR 820 medical device regulations, Good Manufacturing Practices, ISO 9001, ISO 13485 or similar quality systems. Strong writing skills and experience. Able to speak clearly and persuasively in all situations. This position functions as a representative to both internal and external parties. Effective communication is essential in establishing relationships with regulatory authorities, marketing department, manufacturing sites, customers, and other relevant technical functions. Specifics: Competitive salary and bonus structure Full benefits package 401K with match Strong vacation and corporate holiday policy Jadex Inc and its Businesses

do not discriminate in employment based on race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. #J-18808-Ljbffr