HireDiversity

Raritan, NJ, US

REGULATORY AFFAIRS ASSOCIATE III-0616130201

Description

Regulatory Affairs Associate III: Ortho-Clinical Diagnostics, Inc. is seeking a Regulatory Affairs Associate III for our Raritan, New Jersey location to provide domestic and international regulatory support for the Ortho-Clinical Diagnostics franchise, with a focus on the Asia/Pacific region.

Ortho-Clinical Diagnostics believes that many of the world's most serious diseases can be detected before they put a person's life at risk. For that reason, we create the highest quality in vitro diagnostic products that give health professionals the knowledge they need to determine the best treatment. As a Johnson & Johnson company, our work provides people around the world with the potential for a better quality of life at every stage of their life. We give people the power of knowing about conditions early to make the right decisions for a faster path to health.

Position to determine strategies to obtain appropriate approvals and registrations, and prepare complex submissions for assigned projects consistent with established regulatory policies. Provide guidance to Worldwide Marketing, Research & Development, Clinical and Operations departments for the preparation of assigned regulatory submissions in compliance with global regulatory requirements. Represent Ortho-Clinical Diagnostics to domestic and foreign regulatory agencies and work independently to identify and obtain data needed to support regional regulatory strategies.

Qualifications


Qualified applicants will have a Bachelor's degree in a scientific discipline and five years of experience in Regulatory Affairs. Alternatively, employer will accept a Master's degree in a scientific discipline and three years of experience in Regulatory Affairs. Experience must include application of international regulations in registration of in vitro diagnostic devices and medical devices. Experience with EU In-Vitro Diagnostic Directive (IVDD); EU Medical Device Directive (MDD); cGMP regulations; and Asian/Pacific regional regulations, specifically within China, is required. Up to 10% domestic and international travel.

Please mail or fax your resume indicating Requisition Code 0616130201, to: Everette Brown, Global Recruiting, Ortho-Clinical Diagnostics, Inc.; 1001 Highway 202, Raritan, NJ 08869; See us on the World Wide Web at www.jnj.com. Ortho-Clinical Diagnostics, Inc. has a strong commitment to diversity and welcomes applications from all individuals. EOE M/F/D/V.

Primary Location:North America-United States-New Jersey-Raritan
Organization: OCD Inc. (6118)
Job Function: Regulatory Affairs