Location: Nashville,TN, USA
Overview
Magnera's purpose is to better the world with new possibilities made real. For more than 160 years, the originating companies have delivered the material solutions their partners need to thrive. Through economic upheaval, global pandemics and changing end-user needs, they have consistently found ways to solve problems and exceed expectations. By bringing together these legacy companies, the distinct scale and comprehensive portfolio of products will bring customers more materials and choices. With a combined legacy of resilience, Magnera will build personal partnerships that withstand an ever-changing world.
Magnera emerges as a new global leader in the Specialty Materials and Nonwovens industry. Our purpose is to better the world with new possibilities made real. By continuously co-creating and innovating with our partners, we develop original material solutions that make a brighter future possible. With a breadth of technologies and a passion for what we create, Magnera's solutions propel our customers' goals forward and solve end-users' problems, every day. With 46 global manufacturing facilities, you get our solutions faster from closer locations and a lower environmental impact. Become part of a dynamic team that champions passion and creativity to better the world.
Magnera is seeking a Product Compliance Specialist located in Charlotte, NC or Nashville, TN, and will report into our Regulatory and Compliance Manager. The product compliance specialist will accurately assess product compliance with relevant regulations and safety standards, support cross-functional teams in integrating complance requirements, ensure products are safe for their intended use, ensure proper documentation, and minimize compliace risks across the business.
Responsibilities
* Monitor and interpret legislation and regulatory requirements related to raw materials, product development, manufacturing, labelling to provide key stakeholders with relevant information and guidance on compliance topics. Understanding of local and international regulations is highly valued
* Maintain awareness of, and respond to ongoing product safety concerns on substances present or potentially present in products.
* Identify and specify product compliance testing requirements, ensure appropriate processes are in place and that compliance testing is performed in a timely manner.
* Perform vetting of raw materials for compliance and provide technical know-how on ensuring new raw materials meet all relevant requirements.
* Address product compliance related customer enquiries and concerns, investigate implications and formulate responses.
* Develop and maintain standard compliance responses for standard enquiries where appropriate.
* Review potential product compliance issues and recommend / be involved in programs to assess how to address and resolve.
* Identify and propose potential process and procedure improvements, in collaboration with manager.
* Properly escalate identified issues, potential risks and consult with Manager in decision making and solutioning.
* Cross -functional collaboration including Innovation (R&D), Quality, Sales and Customer Service, Procurement, legal and manufacturing.
* Collaborate with external laboratories/institutes in relation to product compliance issues.
* Recommend /assist with additional controls necessary to ensure product compliance is addressed under risk assessment approach, hazard analysis/product safety systems.
* Assist to maintain product compliance in line with legal and company product compliance policies.
* Ensure good record keeping of ongoing work on product compliance topics and customer responses. Continuously maintain and update relevant databases and information media.
* Provide support for customer, authority visits and audits as required.
* Maintain up to date all relevant department procedures and instructions in line with company's Quality Management System.
* Involvement in specific compliance related projects as required by manager.
* Maintain and manage the regulatory files, including confidential linformation.
* Prepare/coordinate Product Safety documentaion as needed such as migration studies, biocompatibility testing etc., supporting internal and external requets.
* Develop and maintain regulatory databases as needed.
* Provide accurate and timely information to internal and external customers.
* Other projects and activities will be assigned as necessary to ensure product complaince to customer requirements.
Qualifications
Education/Experience
* Completed a master's or at least a Bachelor's degree in chemistry or a comparable education with a clear chemistry focus.
* Ideally a background in relevant industries:
* Paper/nonwoven industry and/or plastics and polymer manufacturing industry
* Food, packaging, in particular food packaging
* Pharmaceuticals
* Tobacco
* Cosmetics, hygiene, health care
* 3-5 years previous experience in similar or related role
* Hygiene/product safety training and/or a specific training / specialization on compliance issues are an advantage.
* Previous working experience in a manufaturing environment
* Knowledge of food contact products is a strong advantage
* Knowledge of FDA Title 21, Regulation (EU) 10/2011, Health Canada regulations, and REACH. Ideally has dealt with customer interactions
* Knowledge of product safety management systems
* Proficient with MS Office, in particular excel.
Competencies
* Strong communication skills, both verbal and written, computer literate
* Risk awareness - the ability to identify potential issues for now and future,
* Strong analytical skills, detail-oriented way of working and the ability to synthetize data into comprehensible information,
* Process driven, whilst also maintaining a good level of flexibility and adaptability
* Ability to create and maintain interpersonal working relationships. True team player.
* Ability to plan and prioritize, to deliver in line with deadlines,
* Capability to work in a global environment, with diverse cultures and mentality.
* Proactive, results oriented and determined to succeed,
* Interested in development and learning, as well as optimization.
* Good command of English, other languages are a plus (e.g., German)
* Integrity, confidentiality, and professionalism are highly appreciated qualities in this role.
* Ability to multi-task in a fast-paced environment.
* Ability to use custom regulatory tools.
* Ability and accountability to work independently and as part of a team.
* Strategic problem solving and provide input for policy development.
* Regulatory interpretation and ability to read and interpret legal text.
Benefits
* Participation in Magnera's Bonus Plan
* High Performance Award program: opportunity for cash bonus for outstanding performance
* Paid Time Off: Vacation, Sick, Fixed Holidays, and Floating Holidays
* Medical, Dental, Vision, Life, and Disability Insurance
* 401K Retirement Plan
* Wellness Benefits
If you are interested in this role, please apply on Magnera's website to be considered. Please do not reach out to executives or individuals directly. Thank you.
EOE/Vet/Disability/AA Employer