Regulatory Affairs Associate - (Job Number: 0805856)

Regulatory Affairs Associate - (Job Number: 0805856) DescriptionEthicon, Inc, a member of the Johnson & Johnson's Family of Companies, is currently recruiting for a Regulatory Affairs Associate located in Raleigh, North Carolina Ethicon, Inc. develops and markets products for surgery, wound management and advanced wound care treatment. Products are marketed through four divisions: Ethicon Products for precise wound closure and tissue repair; Cardiovations for minimally invasive cardiac procedures; Ethicon Women's Health & Urology for minimally invasive women's health procedures; and Johnson & Johnson Wound Management for hemostasis and advanced wound care. The Regulatory Affairs Associate will support project teams to obtain U.S. and international regulatory approval for Closure Medical Corporation products. They will ensure compliance with U.S. and international regulatory requirements for design, manufacture, and distribution of Class II and III medical devices. This position will publish high quality regulatory submissions and technical files on a timely basis. In addition, they will administer the process for review and approval of medical device labeling, and ensure compliance to U.S. and global labeling requirements. This position will compile relevant regulatory submissions in support of timely U.S. marketing applications (IDE & PMA). Prepare and maintain technical documentation for CE Marking of new products and registration in other international markets. The Regulatory Affairs Associate will maintain complex files and document management systems and will maintain and archive all regulatory documentation. They will also coordinate labeling review and approval for U.S. and internationally distributed products. A minimum of a Bachelors degree in a scientific or related field is required. At least 5 years of overall industry experience is required. A minimum of 3 years Regulatory Affairs experience is required. This includes maintaining design controls, submissions for new products and risk management. Previous experience with 510K submissions is required. PMA and Class III experience is preferred. Experience preparing and maintaining technical documentation for CE Marking of Class II and III products is a plus. Experience with Global Device labeling is preferred. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! Apply Now