Regulatory Affairs Senior Project Manager - (Job Number: 0800866)

Regulatory Affairs Senior Project Manager - (Job Number: 0800866) DescriptionETHICON, Inc., a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Senior Project Manager of International Regulatory Affairs; this position can be located at any of ETHICON'S locations World Wide. 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 Project Manager of International Regulatory Affairs will help ensure that all ETHICON, Inc. medical products are legally marketed globally, through the most strategic regulatory pathways; to review changes made to existing products in order to assess potential impact; to communicate existing policies and changes in the international regulatory environment to management; and to educate associates on international regulatory policies and practices. Will work independently to identify and obtain data needed to support regional regulatory strategies and execute regulatory strategies for new registrations and re-registrations of products in regional markets as assigned, in collaboration with international affiliate regulatory. Liaison with affiliates market(s) to establish strong communication and positively impact Ethicon product registrations in those markets. Liaison with worldwide marketing to ensure alignment of priorities in applicable regions. Will provide regulatory guidance to project teams, including accurately and completely communicating regulatory risks for both the project teams and senior management alike. Will manages projects and day-to-day operations within department. A BS or BA is required. A minimum of 2 years experience in an FDA-regulated industry is required. A minimum of 1 year QA/Regulatory Affairs experience is required. Knowledge of Medical Device Directives is preferred. Familiarity with global regulatory systems and device regulatory requirements is preferred. The ability to travel 10% of the time both domestically and internationally 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