Regulatory Compliance Specialist

Regulatory Compliance Specialist

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

This position provides regulatory support in regards to several internal and external processes for the regulatory compliance of clients final products including: ingredient disclosure, Safety Data Sheets, WERCSmart, DOT hazardous materials shipping, US Customs, and the management of DEA controlled substances.

This position reports to the Compliance Manager and will interface on a regular basis with the various internal regulatory staff. Other key stakeholders include Sales, Legal, R&D, Quality, Logistics Centers and Manufacturing sites.

Key Responsibilities

• Compliance Activity-Customs & Border, Controlled Substances
• Support activity surrounding Import compliance for US Customs & Border, Health Canada, Transport Canada
• Support activity surrounding US DOT Hazardous Materials Shipping
• Support activity surrounding to DEA Licensing for logistics centers and Year End Diversion tabulation
• Support activity for FDA- ACE submissions
• Database Management
• Support maintenance of various databases including: clients internal ingredient disclosure database, clients website, TDS, Customs, and the external WERCS portal for product registration
• Provide reliable interpretations of regulations and guidance documents
• Assists in the tracking, archival and retrieval of regulatory information for website submissions/licensing following instructions from supervisor

Qualifications

• BA/BS degree required in the natural or Life Sciences.
• 1-2 years in the area related to Regulatory Affairs/Regulatory Operations
• Experience in consumer products industry and DEA regulated products is highly preferred
• Able to read, understand, and apply regulations to company's activities
• Demonstrate a basic understanding of the rules governing development and approval of SDS, formulation, and Pharmaceuticals/Medical Devices
• Familiarity with the structure of a regulatory submissions via web portal and/or dossier
• High attention to detail
• Excellent database programming, word processing and computer skills
• Must be team oriented and be able to work well with others
• Exhibit some independent problem solving skills on routine problems
• Able to work independently and as part of a team within deadlines as imposed by internal guidelines
• Ability to provide metrics/progress reports on project milestones