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Regulatory Specialist


   Location: Wallingford CT, Parsippany NJ, United States (US)
   Job Function: Innovation Management
   Career Level: Professionals
   Company: Röhm America LLC

WHAT WE OFFER
As a leading supplier of methacrylate chemicals worldwide we are active in various markets and supply our products for a wide range of applications. At Röhm our strength is our employees. With their ideas and passion, they actively contribute to our success story. Become part of our team and make your career goals come true. Röhm offers a creative and international work environment plus on-the-job training - for career changers and professionals. With us, you can expect development opportunities for your future.
 

OVERVIEW

 

The Regulatory Specialist supports the global strategy of the Molding Compound (MC) Medical, Automotive, and LEO business segments and the local strategy of the MC Region America (RAM) markets. Together with the Compliance & Regulatory Manager, the Regulatory Specialist ensures that all products & processes comply with relevant regulatory requirements to support the existing business and our MC business's growth.

 

RESPONSIBILITIES

 

  • Provides information on regulatory compliance issues, Regulatory Certifications and Product Certificates of Analysis related to Roehm America LLC's MC products directly to customers
  • Provide support for the registration and certification of our products to applicable regulatory agencies/authorities, including testing for Molding Compounds
  • Provide support to ensure that Product Safety information and Technical Literature (SDS, TDS) are accurate and complete, as well as support the RAPP program 
  • Provide support to actively maintain and manage specifications, recipes (incl. color), and corresponding databases.
  • Manages raw material specs and EMP (first sample check) for Region America (RAM)

 

REQUIREMENTS

 

  • Bachelor's degree required, graduate degree preferred in a relevant field such as toxicology, chemistry, biochemistry, or related technical field.
  • Minimum of 3 years of relevant work experience, including employment with a multi-national chemical manufacturer/supplier.       
  • Minimum of 3 years of experience within a global regulatory/toxicological department.
  • Expert technical understanding of medical plastics and their applications, class I or II
  • Extensive knowledge and understanding of regulations. Globally for Medical application (ex: ISO 10993, USP class VI, ISO 13485, Prop 65) and locally for automotive and LEO segment
  • Experience in reading, understanding, and interpreting global regulatory requirements as related to business support.
  • Ability to travel both domestically and internationally up to 20%


YOUR APPLICATION

To ensure the fastest processing of your application please apply online via our careers portal at https://www.roehm.com/en/career.

If you have any questions regarding your application or the application process please contact: Nick Foster
 at nick.foster@roehm.com and refer to the Requisition ID cited below.

 

Roehm America LLC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, gender, sexual orientation, national origin, disability status, protected veteran status or any other legally protected status. Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please inform us if you require a reasonable accommodation to apply for a job or perform the job.

 

Please note that Röhm will not accept any unsolicited application documents sent by staffing firms. Röhm works in conjunction with preferred service providers and will not pay any fee to staffing firms in the absence of an appropriate framework agreement. Should Röhm receive a candidate profile from a staffing firm with which it has no framework agreement and should this candidate subsequently be considered in the recruitment process or offered employment no claims from the staffing firm will be entertained in this regard.

Requisition ID:  608


Nearest Major Market: New Haven
Nearest Secondary Market: Hartford