Manager, Scientific Operations - Irvine California

Company: Disability Solutions
Location: Irvine, California
Posted On: 02/06/2025

The J&J MedTech Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.\rJohnson & Johnson MedTech, a member of Johnson & Johnson family of companies, is recruiting for a Manager, Scientific Operations& Clinical Evaluations. This position can be located remotely with preferred locations in Raritan, NJ or Irvine, CA.The Manager, Scientific Operations & Clinical Evaluations, will provide strategic oversight and governance ensuring compliance in Sci Ops functions charged with delivery of key regulatory and medical documents. You will lead a diverse Sci Ops team based globally and will ensure the identification and retention of high potential individuals through active engagement, motivation, employee development, and promotion.Specifically, the Manager will lead the execution of Clinical Evaluations, State of the Art Reports, Literature Reports, Safety Surveillance Assessments, and Summaries of Safety and Clinical Performance (SSCP) for multiple MedTech portfolios with a focus on Electrophysiology, Neurovascular Care, and/or Aesthetic Reconstruction. The manager will provide leadership and maintain relationships through extensive interdependent partnering, benchmarking, and forming strategic alliances with cross functional business partners to drive key business goals and objectives. Furthermore, the manager will lead interactions with the Notified Body and the drafting and alignment on response strategy and execution.Responsibilities:

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• Lead a team of medically proficient scientists and technical writers across the various J&J Med Tech franchises to compile and analyze product related safety and performance data, collaborate on strategy, draft reports and coordinate approvals.
• Be responsible for the effective optimization and harmonization of Scientific Operations processes within MedTech while aligning with available guidelines.
• Ensure the CER and SSCP processes are linked to appropriate Quality Systems and Regulatory Processes to ensure information is accessible where needed and will develop, implement and be responsible for an effective communication model.
• Generate materials, lead workshops, and deliver training to ensure adequate implementation of guidelines and contribute to the professional development of employees.
• Develop and supervise performance and compliance metrics providing visibility of issues and enabling risk mitigation, corrective and preventive action to be taken as needed.
• Partner with R&D, Medical Affairs, Clinical, and Regulatory in the establishment of appropriate routes of conformity for clinical evaluations for new products introductions and product design changes.
• Track and trend Notified Body questions and observations across applicable MedTech franchises to improve processes and enhance compliance. Translate insights into viable process and solutions that create value.
• Manage budget and business cycles.
• Oversees administrative tasks including tracking, follow-up, filing, and reviewing documentation.
• Coaches and trains junior colleagues in techniques, processes, and responsibilities.
• Integrates Johnson & Johnson's Credo and Leadership Imperatives into team goals and decision making.\r\r More...

      

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