Regulatory Affairs Specialist

A Few Words About Us - 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. Role profile: This role will be responsible for co-ordination of global regulatory submissions for in vitro diagnostic devices. Responsibilities will include:  • Partnering with global regulatory contacts to understand requirements for product registrations for new and modified products  • Partnering with global regulatory contacts to plan, develop and submit product registration applications for new and modified products  • Obtaining and maintaining documents required for global registrations such as Certificates to Foreign Government and Certificates of Free Sale.  • Assisting with tracking of global registration status of all products.  • As required, performing labelling reviews/approvals.  • Researching and consolidating global regulatory requirements to enable future development of global regulatory strategies.  • Assisting in the development of best practices for Regulatory Affairs processes  • Degree qualified, preferably in a scientific or technical field  • At least 2 years of medical device, diagnostic or related industry experience.  • Knowledge and understanding of US, EU and international medical device regulations.  • Excellent verbal and written communication skills  • Strong organizational and project management skills. • Strong interpersonal, negotiation and problem solving skills; detail oriented  • Ability to work independently and collaboratively with minimal supervision  • Working knowledge of MS Office programs (Word, Excel, PowerPoint, Outlook) and electronic document management systems Warm Regards, NIMISHA DROACH Integrated Resources, Inc IT REHAB CLINICAL NURSING Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012 & 2013 (7th Year) Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70 (Direct) 732-429-1630 Tel: (732) 549 2030 x 226 Fax: (732) 549 5549