Regulatory Affairs Engineer

Role Overview

• Insure that Amcor Flexibles Converter & Distribution (AFCD) products are safe for their intended end uses and fulfill relevant regulatory compliance requirements.
• The scope is inclusive of product safety and regulatory guidance for raw material selection, product end use(s), reclaim and disposal.
• Maintain and manage product safety and regulatory information in an efficient and confidential manner.
• Support the business by addressing product safety and regulatory needs of AFCD’s internal and external customers.
• Gather product safety information from suppliers regarding raw materials used in products to facilitate timely response to customer inquiries.
• Provide feedback and information to fulfill customer regulatory needs.
• Act as a primary interface for product safety and regulatory affairs.
• Actively participate in the development of strategic programs for Product Safety, and Regulatory Affairs.
• Prepare/coordinate Product Safety documentation as needed such as migration studies, biocompatibility testing etc., supporting internal and external requests.
• Provide specialized product safety and regulatory support as needed including US EPA pesticide renewals or modifications.
• Actively participate in gathering knowledge of new regulations affecting AFCD products.
• Maintain and manage the regulatory and product safety files, including confidential information.
• Develop and maintain regulatory databases as needed.
• Develop expertise and knowledge regarding specialized testing associated with product safety, food contact compliance statements and other regulatory requirements.
• Maintain and support the REACH compliance for AFCD products.
• Use of ERP and other tools that holds product safety information including Bill-of-Materials, SDS, Product Safety testing, new chemical review of raw materials proposed for use.
• Meet the regulatory needs of AFCD’s internal and external customers including: obtaining product safety information from suppliers; preparation of product Safety Data Sheet (SDS), Article Information Sheet (AIS) or Article Exemption letters; preparation of product regulatory compliance letters which address customer’s needs and response to product regulatory questionnaires.
• Provide accurate and timely information to internal and external customers.
• Use of the Sphera Solutions Intelligent Authoring tool to create SDS/AIS and regulatory declarations.
• Database administration and maintenance of new or completed regulatory requests.
• Consolidation and organization of vendor certifications.
• Supplier interaction, requests and follow up.
• Refine processes and procedures, for issuance of product regulatory certifications.
• Conduct research as needed for product compliance requirements.
• Prepare and submit documentation for review to Agencies such as Health Canada and FDA as required for products requiring registration.
• Regulatory interpretation and ability to read and interpret legal text.
• Strategic problem solving and provide input for policy development.
• Development of Regulatory Data Sheet (RDS) and/or Product Stewardship Information (PSI) documents.
• Other projects and activities will be assigned as necessary to ensure product compliance to customer requirements.

Requirements

• BS degree or product regulatory experience
• Ability to multi-task in a fast-paced environment
• Strong accountability for completion of goals and objectives
• Knowledge of FDA Code of Federal Regulations (CFR) Title 21, Regulation (EU) 10/2011, Health Canada regulations, REACh
• Expertise in establishing sound audit and testing practices applicable to regulatory compliance
• Ability to use custom regulatory tools, standard office based productivity tools (i.e. MS Office) and ERP tools
• Demonstrated ability to effectively establish proper priorities and to communicate complex information clearly and concisely and apply knowledge of subject matter related to product safety and regulatory compliance
• Speaks and writes clearly and persuasively. Responds well to questions. Employs active listening skills. Demonstrates group presentation skills; presents information, ideas, conclusions and abstract concepts effectively with customers, vendors and internal project teams and individuals
• Ability and accountability to work independently and as part of a team
• Proactively seeks and seizes opportunities to improve the company’s offerings and overall positioning. Develops and refines strategic plans and action plans to achieve declared objectives. Effectively communicates / sells those plans to others, gathers and incorporates further input where appropriate and then implements action steps efficiently and prudently
• Ability to read, analyze, and interpret common scientific and technical journals, and legal documents
• Gathers and analyzes information skillfully and efficiently. Prioritizes and identifies causal connections, related issues and actionable alternatives. Applies practical criteria to decision alternatives in order to choose course of action. Considers and articulates implications for implementation.
• ISO 9001, GFSI standards and ISO14000 experience preferred.
• Prior experience in product safety and/or regulatory compliance role
• BS degree in a technical field such as Biology, Chemistry, Engineering

Tech Stack

• ERP

Benefits

• Medical, dental and vision plans
• Flexible time off, starting at 80 hours paid time per year for full-time salaried employees
• Company-paid holidays starting at 8 days per year and may vary by location
• Wellbeing program & Employee Assistance Program
• Health Savings Account/Flexible Spending Account
• Life insurance, AD&D, short-term & long-term disability, and voluntary benefits
• Paid Parental Leave
• Retirement Savings Plan with company match
• Tuition Reimbursement (dependent upon approval)
• Discretionary annual bonus program (initial eligibility dependent upon hire date)