Principal

• Performs brokerage and insurance regulatory sales supervision functions
• Approves or rejects a subset of business processes including rollovers, securities and/or insurance transactions
• Determines whether transactions are in conformance with regulatory requirements
• Conducts informal business practice reviews to identify trends and/or irregular trading activity
• Assists with regulatory exams and requests

Principal Review Specialist overseeing brokerage and insurance regulatory sales supervision

Principal Review Specialist

Principal Review Specialist performing brokerage and insurance regulatory sales supervision. Ensuring compliance with regulatory standards and mitigating risk within the Fifth Third Bank.

• responsible for training the user community on Epic applications
• serve as the expert on Epic clinical applications and associated ProMedica clinical or operational workflows
• build, test and maintain the training technical environment
• create and maintain high-quality training materials
• coordinate super users training for the application

IT Principal Trainer providing Epic applications training

Principal Trainer – Cupid/Radiant

IT Principal Trainer responsible for training users on Epic applications. Creating training materials and coordinating super user training within a non-profit health care organization.

• Evaluate medical device products and materials for biological safety per international medical device regulations and standards, GLP (US FDA Good Laboratory Practice) guidelines, and internal procedures.
• Design, initiate, coordinate, and interpret laboratory investigations for biocompatibility and toxicology studies for medical device materials and products.
• Apply technical expertise to solve biocompatibility problems related to the ISO 10993 standards and regulatory authority requirements for product safety.
• Liaise with internal and cross-functional team members to review existing product documentation and coordinates, together with more senior staff, biocompatibility test strategies to ensure appropriate planning and execution of required testing and completion of relevant deliverables.
• Review, interpret, and summarize testing data and ensure appropriate documentation and coordination of central documentation procedures required for risk assessment report completion.
• Interact closely with and provide technical guidance and expertise to internal stakeholders (e.g., R&D, Preclinical, Clinical Affairs, Regulatory Affairs, Medical Safety, Manufacturing, Quality Engineering, and Supplier Management) and external partners on medical devices across the entire product lifecycle.
• Identify and evaluate potential risks and drive resolution with team members, peers, and management.

Principal Toxicologist ensuring biological safety of surgical medical devices

Principal Toxicologist

Principal Toxicologist assessing biocompatibility and toxicology of surgical devices at Johnson & Johnson. Collaborates with various teams ensuring compliance with medical device regulations and standards.

• Evaluates medical device products and materials for biological safety per international medical device regulations and standards, GLP (US FDA Good Laboratory Practice) guidelines, and internal procedures.
• Designs, initiates, coordinates, and interprets laboratory investigations for biocompatibility and toxicology studies for medical device materials and products.
• Applies technical expertise to solve biocompatibility problems related to the ISO 10993 standards and regulatory authority requirements for product safety.
• Liaises with internal and cross-functional team members to review existing product documentation and coordinates, together with more senior staff, biocompatibility test strategies to ensure appropriate planning and execution of required testing and completion of relevant deliverables.
• Reviews, interprets, and summarizes testing data and ensures appropriate documentation and coordination of central documentation procedures required for risk assessment report completion.
• Interacts closely with and provides technical guidance and expertise to internal stakeholders (e.g., R&D, Preclinical, Clinical Affairs, Regulatory Affairs, Medical Safety, Manufacturing, Quality Engineering, and Supplier Management) and external partners on medical devices across the entire product lifecycle.
• Can support regulatory/notified body requests as part of audits and file/product submissions/reviews in applicable markets.
• Maintains effective communication of business-related issues or opportunities to next management level and if necessary, SMEs, via proper communication methods and/or tools.
• Identifies and evaluates potential risks and drives resolution with team members, peers, and management.
• Participates in continuous improvement activities and actively participates in shaping processes and procedures.
• Responsible for communicating business-related issues or opportunities to next management level.
• Responsible for following all company guidelines related to health, safety, and environmental practices as applicable.
• For those who supervise or manage a staff, 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, if applicable.
• Responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies, and procedures.
• Supports regulatory/notified body requests as part of audits and file/product submissions/reviews in applicable markets.
• Directly interacts with notified body (TUV, BSI) and regulatory representatives.
• Performs other duties assigned as needed.

Principal Toxicologist for medical devices at Johnson & Johnson's R&D.

Principal Toxicologist responsible for assessing biocompatibility and safety for medical devices. Working in a hybrid role with R&D at Johnson & Johnson in Ohio and New Jersey.

Principal jobs in Ohio

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Principal Review Specialist

Principal Trainer – Cupid/Radiant

Principal Toxicologist

Principal Toxicologist