The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Design and maintain a comprehensive training program
Create and maintain training files for tissue bank staff
Ensure all training files are in compliance at all times with SOPs, Regulations, and Standards
Ensure all training is documented and filed accordingly
Ensure all annual SOP reviews are prepared, performed, documented, and filed appropriately
Develop and deliver ongoing training content and presentations
Perform onboarding training as required and ensure all onboarding training is complete prior to the new employee starting work
Perform and/or ensure all initial competencies and annual competencies are performed, documented, and filed
Work closely with Document Control to ensure all new and revised procedures, work instructions, forms, etc. are trained on in a timely manner
Track and trend metrics and prepare trends and graphs as directed by management
All aspects of training position may be performed for Integra staff and outside agency staff
Maintaining and provide donor metrics to management.
Assist in creating/revising policies, procedures, specifications and forms
Maintain up to date knowledge with respect to tissue banking activities performed at the site
Any other duties or responsibilities necessary or as assigned
BS degree in a scientific discipline (Chemistry, Biology, Physics, Bio-Medical Engineering/Chemical Engineering, etc.) or equivalent education/experience with at least 1 year of tissue/ocular donor record review experience or a High School diploma with at least 4 years of experience in tissue/ocular donor record review.
Knowledge of AATB Standards and FDA 21 CFR 1271 regulations.
Preferably CTBS certified.
Experienced and proficient with Excel, PowerPoint, and Word programs.
Organized, attention to detail and maintain appropriate analytical skills.
Experience in applying statistical methods for quality improvements.
Organized file management.
Strong communication skills, both written and verbal.
Professional team player
Able to lift 40 lbs.
Internal Number: F1 21 P18
About Integra LifeSciences
Changing lives. Building careers.
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 employees worldwide. Integra’s common stock is listed on The NASDAQ Stock Market under the symbol “IART.”