Regulatory Affairs Specialist
Loparex LLC

Job Info

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Regulatory Affairs Specialist

The Regulatory Affairs Specialist ensures product safety and legal compliance regarding global chemical regulations in product development across the supply chain. Responsibilities include providing product stewardship support regarding regulatory issues for the company's products and market/applications, monitoring and analyzing regulatory trends and positions in the industry, ensuring the efficient completion of stewardship-related product introduction deliverables, and supporting sustainable development alternatives and concepts for the company's product lines.

Responsibilities and Duties:

• Processing customer inquiries regarding regulatory affairs and product safety.
• Conflict resolutions.
• Creation of product safety requests.
• Review of raw material.
• Preparation of declarations of conformity
  • Product formulary disclosures
    • Approval process
  • REACh
    • SVHC/banned substances
    • SCIP
  • TSCA
  • Other country chemical registration status
  • ROHS/WEE
  • CONEG
  • US California Prop 65
  • Conflict Minerals
  • PFOA/PFOS
  • CMR substances
  • Assist with Drug master file filing and updates
  • FDA
    • Food Contact
    • Medical Devices
    • Pharma
      • USP General Chapters < 232> Elemental Impurities-Limits and < 233> Elemental Impurities-Procedures.
      • < 462> Residual solvents
  • Nitosamines
  • EU MDR - SVHC/
  • BfR-food contact
  • Other food contact research as needed
  • Metal catalysts
    • Tin
    • Platinum
    • Rhodium
  • Residual VOC
  • Pesticides
  • Paper
    • US FSC/EU Timber rules
  • Microplastics
  • Others as legislation is passed
• Help with registration of compostable/biobased products.
• Training, email notification, and internet research on new or changed legal requirements.
• Maintenance of the database with supplier-specific information for the preparation of declarations of conformity.
• Communication with all Loparex sites.
• IMDS - Automotive - GADSL.
• Sampling products for shipping for migration analysis.
• Perform facility audits regarding regulatory compliance.
• Other duties as assigned.

Qualifications and Skills:

• Bachelor's Degree in Chemistry or Environmental Science preferred, or equivalent combination of education and experience.
• 3-5 years of regulatory affairs experience required.
• Knowledge of silicone/polymer chemistry.
• Knowledge of engineered films, siliconized papers, and films highly preferred.
• Ability to work in a cross-functional team.
• Understanding of the product and market portfolio with respect to how they impact health, safety, and environmental issues.
• Ability to understand technical information and science as it applies to products, and the ability to translate into a business context.
• Experience in dealing with internal and external customers.
• Fluent in English, other languages a plus.
• Excellent organizational skills.
• Ability to work accurately and quickly under operational timeframes.
• Ability to communicate with management and employees efficiently and professionally.

Benefits:

• Medical, Dental, and Vision Insurance
• Telehealth
• Health savings account with generous annual employer contribution
• Fitness reimbursement program
• Development and career growth opportunities
• Competitive 401(k) matching program

We are an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other category protected by applicable law.

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