Regulatory Affairs Associate I - (Job Number: 0805134)

Regulatory Affairs Associate I - (Job Number: 0805134) DescriptionEthicon Endo- Surgery, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Regulatory Affairs Associate I, located in Cincinnati, OH. Ethicon Endo-Surgery, Inc.- develops and markets advanced medical devices for minimally invasive and open surgical procedures. The company focuses on procedure- enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastro- intestinal health, gynecology and surgical oncology. The Regulatory Affairs Associate I will assist with activities necessary for the timely preparation, writing & submitting of international registrations (technical files), 510(k)s (Pre-market Notification), IDEs (Investigational Device Exemptions), PMAs (Pre Market Approvals), PDPs (Product Development Protocols), & all related amendments & supplements. The ideal candidate will assist with general regulatory maintenance / surveillance of products once they are placed on the market, including, but is not limited to, review of Change Authorization Forms & for subsequent regulatory impact. Collect thorough & factual, data & information to complete product registrations or submissions Develop & maintain an appropriate level of professional competence through participation in continuing education programs. Document regulatory decisions to file/not to file new or amended submissions (510(k)s / technical files. Exhibit a competence in US & foreign government regulations regarding the manufacture & distribution of medical devices The Regulatory Affairs Associate I will manage a significant amount of proprietary information in an extremely confidential manner as impropriety with this information can lead to loss of intellectual property. Organize & balance a multitude of projects simultaneously to meet aggressive product marketing strategies & be prepared to assist other regulatory professionals with high priority projects as assigned by the department director. Provide support to RA product development team members & assist with various product development team projects as assigned (one, or may cross several, franchise groups) Review government, trade association, industry, medical & scientific publications to keep informed of, developments that may impact the regulatory status of products & communicate these developments to senior regulatory staff & appropriate levels of management as directed. Review immediate carton labels, package inserts & promotional materials for compliance with US & foreign government regulations Stay continually aware of new product development activities by supporting senior RA staff on assigned product development teams. Supports activities necessary to gain & maintain US & foreign regulatory approval / clearance on new & modified products. Work at the direction of the managerial regulatory staff. A bachelor's degree in a scientific discipline, biomedical engineering, or related area or an Associates degree combined with at least 5 years experience as a regulatory specialist or equivalent regulatory work experience. The successful candidate must have 3-5 years of experience conducting regulatory activities that achieved either domestic or international regulatory approval/clearance of new and modified medical devices.Knowledge of current US and foreign government regulations regarding manufacturing and commercial distribution of medical devices is preferred. Knowledge of biomaterials, biomechanics, sterilization technology, anatomy & medical terminology is desired. RAC certification by the Regulatory Affairs Professional Society is desirable. Excellent communication, interpersonal, and decision-making skills are required. Moderate travel may be required To learn more about opportunities with the Johnson & Johnson Family of Companies, visit us at http://www.jnj.com/careers . Johnson & Johnson is committed to diversity and invites all interested candidates to apply for positions of interest. EOE M/F/D/V Please note: In order to be considered eligible for an interview, candidates must apply online through the appropriate web portal. 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