Regulatory & Compliance Sr Specialist

The Regulatory & Compliance Sr Specialist is responsible for managing regulatory approvals for ICS products to ensure compliance with U.S., Canadian, and European safety standards. This role leads new product and product revision approvals with external agencies and serves as the internal expert on regulatory compliance. In addition, the Regulatory Engineer supports and maintains the Quality Management System (QMS) in alignment with ISO 9001, including audit support and continuous improvement activities. The role requires effective communication across all levels of the organization and provides guidance to engineering, sales, and customers on compliance requirements.

Essential Job Duties and Responsibilities

• Serve as the internal technical expert for product regulatory compliance for all ICS businesses
• Manage projects and activities related to compliance for new products and product revisions
  • Complete necessary testing & documentation for successful submission to global regulatory agencies. 
  • Work with outside Approval Agencies and Notified Bodies to issue Approval Reports
    • Typical requirements are for US & Canada (FM – Factory Mutual), CE, and ATEX for Europe
  • Create Document of Conformity (DoCs) as required for certified products and systems
  • Create and maintain document files for self-certified products
• Act as the “Authorized Person”, approving Engineering Change Requests to certified products, drawings, assemblies, deviations, and non-conforming product disposition
• Act as liaison with Approval Agencies; maintain relationships with various executives and representatives of Agencies to develop knowledge of codes and standards by which Nordson equipment is evaluated
• Develop consistent strategies between businesses and plans for achieving and maintaining compliance
• Responsible for keeping businesses up to date on changes and new global regulations
  • This includes coordination with global colleagues on any proposed changes to non-US regulations
• Provide training for product engineers on global safety standards & requirements
• Participate as the Nordson primary or alternate representative to industry safety associations, NFPA 33, 34,660, 67, 68 & 69 committees
• Work with outside agencies during their audits of ICS certified products & processes to ensure compliance
  • For any non-conformities found, drive corrective actions & countermeasures to prevent reoccurrence
• Serve as liaison between ICS and Nordson Corporate for regulatory matters
• Manage incident investigations with field personnel and customers including reporting and documentation
• Support sales team & customers with regulatory issues & questions for Engineered System installations
• Perform regular audits of processes and systems to ensure compliance with quality standards and regulations, such as ISO 9001, internal and external.
• Support and maintain the ICS Quality Management System (QMS) in alignment with ISO 9001
• Plan and conduct internal audits; support external and customer audits
• Drive corrective actions (CAPA) from audit findings and ensure timely closure
• Maintain QMS documentation (procedures, work instructions, records)
• Provide guidance and training on ISO 9001 requirements
• Support management review activities and report key quality metrics.

Education and Experience Requirements

• Bachelor’s degree in Engineering
• 5-7 years of experience with global regulatory approvals for industrial equipment
• Experience with NFPA requirements for spray equipment & booths preferred
• Experience with FM/CSA requirements, CE-Machinery Directive, CE-EMC Directives, CE/ATEX requirements for industrial equipment preferred
• Experience  ISO 9001 and Quality Management Systems (QMS), including audit support

Skills and Abilities

• Strong project management skills
• Highly effective verbal and written communication skills
• Attention to detail
• A self-starter with outstanding planning and organizational skills
• Ability to work independently or as part of a diverse team with diverse cultures across multiple geographic locations
• Ability to interpret and apply regulatory standards and quality system requirements (e.g., ISO 9001)

Working Conditions and Physical Demands

Office Environment: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Travel Required

Estimated - 15% to 20%

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