Senior Project Manager, Regulatory Affairs - (Job Number: 0712005)

Senior Project Manager, Regulatory Affairs - (Job Number: 0712005) DescriptionEthicon, Inc, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Project Manager ' Regulatory Affairs located in Somerville, NJ. 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 Senior Project Manager ' Regulatory Affairs will ensure that all Ethicon, Inc. medical device products are legally marketed globally; to review changes made to existing products in order to assess the impact on safety and effectiveness; to assure that product claims, informational and educational materials conform to Regulatory strategies and current global guidelines; prepare and submit global regulatory submissions on a timely basis, interpret regulations, guidances/policies; communicate existing policies and changes in the regulatory environment to management; and to educate and lead associates on regulatory policies and practices. The Principal Duties and Responsibilities of this position will include interaction with global regulatory authorities as needed, participation on project teams, develop and implement creative regulatory strategies. Manage projects and day-to-day operations within department. Represent the department/project in providing solutions to complex regulatory issues. The Senior Project Manager 'Regulatory Affairs will be a spokesperson for functional area, review and approve marketing and promotional materials. Interpret and communicate global regulations to organizations within the company. Collaborate with international affiliates to support global product registration. Assist in the development and implementation of labeling. A Bachelors degree is required, scientific discipline preferred; an advanced degree desirable. A minimum of 6 years experience in Regulatory Affairs is required. Previous medical device experience is required. Experience with class II medical devices is required, class III experience is preferred. Previous 510K experience is required. Previous experience with both US and EU regulations is required. Conceptual knowledge of all responsible functions is required, knowledge of business areas is preferred.. Must have excellent interpersonal skills, as well as excellent verbal and written communications.Diplomatic in dealing with colleagues at all levels in the organization. Good negotiation skills. Self motivated and able to work in a team environment Demonstrates detailed understanding of global regulatory systems and device regulatory requirements. 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