ny Johnson & Johnson Medical Device Company based in the United States. This position will require up to 30% domestic and international travel. Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales. The business is expected to experience solid growth over the next 5 to 7 years. Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products.
The Robotics Program Director, Medical Operations Shared Services acts as the central lead for Clinical Evaluation Reports (CERs) and related activities for Ethicon Robotics including developing and co-developing strategies with Medical Affairs, Regulatory, R&D, Clinical Affairs and other cross-functional departments. You will be leading and developing CER strategies in support of active devices and those devices containing software for OneMD.
In this exciting role, you will:
- Lead the strategic development of CER requirements/activities (appropriate routes of conformity, data requirements, etc) in support of the Ethicon Robotics program
- Support and assist, as needed, across Medical Operations Shared Services (MOSS) OneMD businesses regarding New Product Development (NPD) strategies for Active Devices and those containing software
- Establish processes and procedures for CERs related to active devices and those devices containing software for OneMD
- Provide training and support to the MOSS team and business partners across OneMD regarding CER requirements related to active devices and those devices containing software
- Primary lead and support for Robotics Medical Operations activities, which include:
- Execute Clinical Evaluation Report (CER) activities, planning and strategies related to the Robotics Program for Ethicon
- Support R&D test and report strategy and design as it relates to data required for CERs and Regulatory Submissions
- Lead efforts to develop “Pre-CE Mark Submission Clinical Review” to be reviewed by TÜV
- Work directly with R&D to author R&D related portions of Pre-CE Mark Submission Clinical Review
- Support development of PMCF Plan for robotics system, components and devices
- Support and lead recurring meetings with Notified Bodies; meetings to provide opportunities for discussions and feedback around various robotic program topics with the goal of addressing concerns to increase likelihood of timely and successful CE Mark
- A minimum of a Bachelor’s Degree is required
- Advanced Degree is preferred
- Minimum 10 years of relevant experience is required
- A minimum 3 years of people leadership experience is required.
- Experience within the medical device industry is preferred
- Experience and knowledge of clinical evaluationreport regulatory requirements, evidence generation, and Clinical Evaluation Report (CER) document creation is required
- Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse eventreporting, medical device risk management processes is preferred.
- Experience with common bio statistical methods is preferred
- Previous experience developing and implementing system processes is preferred
- Regulatory/Notified Body front room auditexperience is required
- Previous budgetary experience is preferred
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.