Senior Regulatory Affairs Specialist

Senior Regulatory Affairs SpecialistIntegrated 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.Client: Direct ClientLocation: West Chester, PAJob Title: Senior Regulatory Affairs SpecialistDuration: 1 year + (Possible Extension)Job Summary:The Recall Regulatory Specialist III will be responsible for leading OUS (outside the US) field action execution activities including managing Field Action Strategy Team meetings, coordinating and preparing document packages to notify regulatory agencies of field action activities, drafting internal and external customer communications, providing updates to FDA and global regulatory agencies, processing and closing Field Actions in a timely manner, and act as support for FDA and regulatory inspections.Responsibilities:• Working knowledge of 21 CFR Part 820, QSR, ISO 13485, CFR 806, and MDD/IVDD requirements is preferred.• The ability to work autonomously and on multiple projects with accelerated timelines is required.• Proven experience leading projects with cross-functional teams is required.• Proven ability to meet timelines is required.• Excellent Investigative skills such as analytical problem solving, fish bone, root cause analysis, etc. is preferred.• Excellent computer (e.g., PowerPoint, WORD, Excel, Vision) communication, and written skills are required.QualificationsEducation• A minimum of a Bachelor's Degree in Engineering or Technical Science is required.• Advanced Degree is preferred.• A minimum of 4+ years of experience in a medical device and/or pharmaceutical industry, and 1+ year within a regulatory role is required.• Experience with field action related activities is preferred.