Senior Regulatory Affairs Specialist - (Job Number: 0806030)

Senior Regulatory Affairs Specialist - (Job Number: 0806030) DescriptionEthicon, Inc, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Regulatory Affairs Specialist located in Somerville, NJ. ETHICON develops and markets products within three divisions: ETHICON Products for wound closure and tissue repair; Johnson & Johnson Wound Management with biosurgical technologies to manage intra-operative bleeding and postoperative leaking, as well as advanced wound care products; and ETHICON Women's Health & Urology with minimally invasive gynecological and urological solutions in stress urinary incontinence, pelvic floor repair and uterine disorders. The Senior Regulatory Affairs Specialist 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 Regulatory Affairs Specialist 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. Bachelor's degree in technical, scientific, or medical/health discipline required. Advanced degree / RAC preferred. Minimum 3 years of experience in a regulated healthcare industry required. Experience with US FDA submissions, such as Pre-Market Notifications, and Special Pre-Market Notifications is required. Experience with Original PMA Submissions, PMA Supplements is a plus. Experience with face-to-face FDA meetings and negotiation is required. Experience with biologics, biopharmaceuticals, or pharmaceuticals are preferred. The ability to travel both domestically and internationally up to 25% of the time required. 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