Associate Medical Director, CHSS - (Job Number: 0717345)

Associate Medical Director, CHSS - (Job Number: 0717345) DescriptionCordis Corporation, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Medical Director, CHSS located in Miami, FL or Warren, NJ. Ground breaking, life changing careers that reward the power of ideas and innovation. For more than 40 years, Cordis Corporation has pioneered less invasive treatments for vascular disease. Technological innovation and a deep understanding of the medical marketplace and the needs of patients have made Cordis the world's leading developer and manufacturer of breakthrough products for interventional medicine, minimally invasive computer-based imaging, and electrophysiology. Today, over 7,000 Cordis employees worldwide share a strong commitment to continue the Company's groundbreaking work in the fight against vascular disease. Cordis Corporation offers tremendous opportunities and world-class resources. Our decentralized structure provides the feel of a small-company environment with big-company impact. We are focused on developing leaders with a broad base of business and cultural skills, along with a strong commitment to the values expressed in Our Credo. By choosing Cordis Corporation, you are choosing to positively impact the lives of millions of people each year. The Associate medical Director, CHSS will assist in maintaining Cordis' Quality Risk Management activities throughout the product life cycle. Report on program effectiveness to quality management and general management of both the Cordis franchise and individual business units. Ensure effective program implementation at all Cordis sites worldwide. Ensure ongoing compliance/alignment with FDA, ISO and other applicable regulatory requirements, and continuous program improvement consistent with industry standards and practices. Evaluate product risks and potential safety issues throughout the entire product life cycle. Evaluate severity of risks for marketed products arising from complaints, nonconforming product reports and trending, quality system deficiencies, and other internal and external sources of quality and risk data. Assess case-by-case need for follow-up actions, such as Corrective and Preventive Action (CAPA), Distributed Product Risk Assessment (DPRA), Quality Leadership Team (QLT) review, Risk/Benefit Analyses, or Failure Mode and Effect analysis (FMEA) revision. Collaborate with New Product Development (NPD) by acting as team member or allocating resources to NPD teams to provide design input from complaints, input into risk management, labeling design and effectiveness and an assessment of the functionality of the product design. Assess serious injuries, malfunctions and drug interactions in support of regulatory agency product surveillance reporting. Ensure that product safety and performance analyses are data driven and scientifically sound. Partner with Epidemiology and Reporting group to support trending and safety signal detection. Ensure that the Site's Quality System is established and maintained in harmony with the Franchise Quality System and in accordance with applicable standards and regulations, and report on the performance of the Quality System to Business Unit Management. Responsible for communicating business related issues or opportunities to next management level. Responsible for ensuring that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. An MD is required from an accredited Medical School. Knowledge and experience within cardiology/radiology and/or drug safety or related activities is required. At least 3 years experience in pharmaceutical/medical device industry in the function area of product safety is required. Working knowledge of medical device reporting (MDR) regulations, ISO 14971 and/or principles or risk/benefit analysis in the pharmaceutical industry is preferred. Regulatory affairs or compliance experience is preferred. Excellent written and oral English communication skills is required. Ability to thrive simultaneously in a global environment is required. Sound knowledge of interventional cardiology/radiology preferred or in drug safety is required. Familiarity with industry principles of all adverse event reporting requirements is required. Prior supervisory experience is preferred. Excellent teamwork and interpersonal skills is required. Excellent organizational and planning capabilities is required. Excellent critical clinical analysis skills is required. Demonstrated leadership skills including team motivation, ability to problem solving, takes initiative, and meet challenges is required. Apply Now