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Job Field: Legal Jobs
Location: Irvine, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>REGULATORY AFFAIRS SPECIALIST III-7162121010DescriptionAdvanced Sterilization Products Division of Ethicon, Inc., a member of Johnson & Johnson''s Family of Companies, is currently recruiting for a Regulatory Affairs Specialist III, located in Irvine, CA.ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit www.aspjj.com or follow us at www.Twitter.com/aspjj.The Regulatory Affairs Specialist III will provide administrative and technical support to regulatory affairs management in order to remain in compliance with all FDA and other U.S. and international regulatory requirements. The Specialist, under minimal supervision, coordinates, compiles, and submits Regulatory documents to FDA and other Regulatory Agencies, including EPA and International Authorities. Also includes the preparation of international documents, including Technical Files. Works with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products. She/ He will provide Regulatory support to project teams, creates detailed Regulatory Plans, includes in-depth team involvement, and Core Team membership for complex projects. The individual will evaluate proposed product modifications for Regulatory impact on a world-wide basis and completes Regulatory Assessments as needed. The individual will ensure compliance with FDA and other applicable regulations and interpretations. Will prepare responses to FDA questions and other Regulatory correspondence The Regulatory Affairs Specialist III requires a general use and application of Regulatory concepts, practices and techniques to develop solutions to a variety of problems of moderate scope and complexity.QualificationsA minimum of a Bachelor''s degree with a minimum of 6 years related experience OR an advanced degree with a minimum of 4 years related experience is required. A degree in Biology, Chemistry, Microbiology or other closely related discipline is preferred. Prior experience in Regulatory Affairs and/ or Quality Assurance is required. Experience in a FDA regulated Environment is also required. Any experience in the Medical Device industry highly desired. Knowledge of FDA regulations and CE is preferred. Experience with 510(k) submissions is preferred. Strong technical writing skills are required.This individual must have excellent organizational skills and strong attention to detail. Good analytical thinking, problem solving and investigative skills are required. Excellent communication skills, both verbal and written are required. The ability to influence others within the organization and cross functionally is required.This position will be based in Irvine, CA and will require up to 10% domestic and/ or international travel.BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of CompaniesPrimary Location:North America-United States-California-IrvineOrganization:Advanced Sterilization Products (ASP)Job Function:Regulatory Affairs

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