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Regulatory Specialist
Regulatory SpecialistFormerra LLC • Cleveland, OH, US
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Regulatory Specialist

Regulatory Specialist

Formerra LLC • Cleveland, OH, US
30+ days ago
Job type
  • Full-time
Job description

Job Description

Job Description

Who We Are

Formerra is a preeminent distributor of engineered materials, connecting the world’s leading polymer producers with thousands of OEMs and brand owners across healthcare, consumer, industrial, and mobility markets. Powered by technical and commercial expertise, it brings a distinctive combination of portfolio depth, supply chain strength, industry knowledge, service, leading ecommerce capabilities, and ingenuity. The experienced Formerra team helps customers across multiple industries to design, select, process, and develop products in new and better ways – driving improved performance, productivity, reliability, and sustainability. To learn more, visit www.formerra.com.

Formerra leads in the market with the following key capabilities :

  • Problem-solving mindset, based on ingenuity and backed by a skilled and experienced commercial team that brings differentiated insights across markets including healthcare, consumer, industrial and mobility
  • Expansive material portfolio, including engineering thermoplastics and traditional polymers across leading material brands
  • Integrated, long-standing relationships with leading, global suppliers
  • Unparalleled and highly specialized technical, processing, and design support
  • Regulatory-compliant material support and expertise

Position Overview

The Regulatory Specialist serves as a trusted advisor who partners with our suppliers, customers, and other interested parties to provide relevant regulatory information and documentation, protects Formerra’s interests by obtaining required medical approvals where applicable, and communicates our ability to meet customers’ process requirements and material specifications.

Essential Duties and Responsibilities

  • Maintain Formerra’s Safety Data Sheet (SDS) repository to reflect the latest versions provided by suppliers.
  • Fulfill customer and internal requests, including IMDS and PPAP requests, with accurate and professional responses.
  • Facilitate the medical approval process as defined within processes controlled by Formerra and its suppliers.
  • Monitor the department’s Outlook inbox and respond to requests or redirect to the appropriate point of contact.
  • Review customer internal material specifications for alignment with supplier specifications.
  • Monitor imports and exports subject to TSCA and TSCA 12b regulations, and as required, notify the EPA.
  • Monitor regulatory changes and determine the impact (i.e. Conflict Minerals Act, REACH, RoHs, etc.)
  • Provide training to internal stakeholders on regulatory requirements, including guidance on using appropriate documents.
  • Other duties as assigned.
  • Qualifications : Education :

  • High School Diploma or GED and 2+ years of experience required in a manufacturing, automotive, healthcare and / or distribution environment.
  • Knowledge of ISO standards is a plus.
  • Experience :

  • Proficiency in Microsoft Office suite (Word, Excel, Outlook, PowerPoint) with the ability to learn new software programs as required.
  • SAP experience strongly preferred.
  • Excellent organizational and critical thinking skills.
  • Ability to prioritize workload, manage multiple tasks, and work independently.
  • Strong communication skills, both written and oral.
  • Ability to foster collaborative team environments and work cross-functionally.
  • Ability to work in a fast-paced environment.
  • Work Environment :

  • Hybrid Schedule : Combination of office and remote work
  • Physical Requirements : Requires remaining in a stationary position for prolonged periods of time, and frequent communication. Must be able to operate computer and other office equipment.
  • Setting : Typical work is in an office environment where the noise level is low to moderate.
  • Disclaimers :

  • Legal authorization to work in the US is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
  • The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.
  • It is the policy of Formerra that all employees are employed at the will of Formerra for an indefinite period and are subject to termination at any time, for any reason, with or without cause or notice. At the same time, employees may terminate their employment at any time and for any reason.
  • Equal Opportunity Employer. All qualified candidates will receive consideration for employment and will not be discriminated against based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, pregnancy, genetic information, creed, citizenship status, marital status or any other consideration prohibited by law or contract.
  • NOTICE : Formerra is committed to ensuring a fair and legitimate recruitment process. We want to alert job applicants to the potential risk of recruitment scams and encourage caution when responding to unsolicited job postings or communications. If you receive a job offer without having explicitly applied through our website or a legitimate job board, please be wary. We will never request sensitive personal information—such as your Social Security number, birth date, or banking details—via email. If you are uncertain about the legitimacy of a job posting or communication, please contact us directly at careers@formerra.com .
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    Regulatory Specialist • Cleveland, OH, US

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