HireDiversity

Somerville, NJ, US

Post-Market Surveillance Manager, Signal Detection-6421130107

Description

Ethicon Surgical Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Post-Market Surveillance Manager, to be located in Somerville, New Jersey OR Cincinnati, Ohio.

The Ethicon Surgical Care business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.

The PMS Manager manages the Post Market Surveillance processes, including supervision of PMS Analysts/Engineers. Directs responsibility for the PMS process for business units within Ethicon Surgical Care & Energy. Manages the execution of the Post Market Surveillance process including Signal Detection, Signal Assessment and Policy/Planning. This individual is accountable for the continued development, refinement and implementation of signal detection and assessment methodologies for both quantitative and qualitative post-market signals. Owns the initiation and maintenance of Post Market Surveillance plans for new products and legacy devices.

The PMS Manager coordinates the monitoring and measurement of reactive and proactive post-market safety & quality signals. Works with internal and external partners to develop/maintain best-in-class signal detection methodologies. Creates and maintains Post Market Surveillance Plans for NPD and legacy products. Organizes and facilitates PMS meetings for the review of individual and aggregate data sets. Maintains the PMS data warehouse inclduing escalation forms and meeting records. Manages projects relating to new product introductions to assure compliant handling, complaint reporting and Post Market Surveillance planning have been represented in the process. Acts as a consultant and provides leadership on Post Market Surveillance projects. Recommends and implements all procedures, systems and training. Coordinates the communication of follow-up letters/inquiries regarding product safety, efficacy and performance with FDA, Competent Authorities, Authorized Representatives and Health Ministries. Assists in providing analysis of trends and factors to Operations and Technical staff management for resolution. Accountable for PMS reporting (semi-annual, annual, bi-annual). Provides field product information to Marketing and R&D as part of the strategic initiative of continuous improvement. Provides input to Succession and Developmental planning for Worldwide Customer Quality and Post Market Surveillance associates. Provides front-room/back-room representation for PMS during internal and third party audits.

Qualifications


A Bachelor's degree in a Scientific, Technical, Engineering, or related field is required. A BSN in nursing will also be considered. A minimum of 8 years of relevant experience is required. General knowledge of statistical applications and auditing practices is required. Technical experience (e.g. systems, software programs, analytical research, etc) is required. Medical Devices/diagnostics and/or other regulated industry experience is required. Supervisory experience is required. A successful track record of collaboration and teamwork is required. Experience working in a cross-functional team environment is required.

Up to approximately 20% international and domestic travel may be required. This position can be located in Somerville, New Jersey OR Cincinnati, Ohio.

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Somerville
Other Locations:North America-United States-Ohio-Cincinnati
Organization: Ethicon Inc. (6045)