Staff Scientist - Toxicologist
Biosense Webster Inc., a part of the Johnson & Johnson family of companies is currently recruiting for a Staff Scientist Toxicologist ! This position will be located in Irvine, CA.
Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. 20 million people around the world suffer from AFIB each year. Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company’s CARTO® 3 System in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.
This is an exciting opportunity for a Toxicologist to join our team in Irvine, CA. The candidate will be responsible for evaluation of medical devices for safety as per local and global regulations. Toxicological reviews and inputs based on guideline documents by regulatory authorities such as US FDA, European notified bodies and other country regulatory authorities. An important part of the job is building and reviewing Toxicology/Biocompatibility documents, initiation of material characterization studies, in vitro and in vivo study design and final toxicological and biocompatibility reports where necessary to support Johnson and Johnson medical device products for registration and throughout the life cycle of the product. Interacts closely and provides consultative direction and technical expertise to R&D, Clinical Affairs, Regulatory Affairs, Product Stewardship, Surgical R&D and Supplier Management within Biosense Webster and potential across J&J franchises. This person is also responsible for evaluation of gaps in both testing and safety supporting information and traceability of product testing to existing product on the market. The primary role is to establish toxicological safety assessments for materials, chemical and product constituents the ensure materials safety for pre-marketed and marketed products.
Key Responsibilities :
- Evaluates Biosense Webster medical devices safety as per ISO 10993 standards
- Builds and peer-reviews Toxicology/Biocompatibility documents
- Designs studies to support biocompatibility testing, reviews and analyze data to create reports. Reviews, interprets, and summarizes raw data from reports and support coordination of central documentation procedures required for reports. Apply technical expertise to solve biocompatibility problems, utilizing ingenuity, business experience and independent judgment.
- Ensures that testing meets all international and domestic test requirements according to ISO (International Organization for Standardization), FDA (Food & Drug Administration) - CDRH (Center for Devices & Radiological Health) and GLP (Good Laboratory Practice)
- Supports activities related to initiation and generation of study proposals and supporting material biocompatibility and analytical testing for regulatory submissions
- Summarizes and interprets raw data from reports and supports coordination of central documentation procedures required for reports
- Interacts closely and provides consultative direction to R&D, Clinical Affairs, Regulatory Affairs, Surgical R&D & Supplier Management within JNJ MD
- May serve as a Project Leader to lead project activity, communicate timelines, deliverables and study outcomes to leadership as well as serve as the primary liaison to the project development team as a single voice of the department.
- Maintains a collaborative spirit of the work environment that is professional and ensures the integrity of others as partners and team members who uphold the Johnson and Johnson Credo in everything that is potentially a marketed product.