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.
Inspect and approve human tissue, materials, reagents, and supplies.
Create, maintain, and inspect to Material and Tissue Specification Sheets.
Ensure all received and approved human tissue, materials, reagents, and supplies are from approved suppliers.
Ensure all tissue remains in quarantine until released appropriately and is stored in a manner that keeps tissue separated and segregated and in approved order for easy identification and pulling for processing, labeling, etc.
Receive and review all required in-process testing results.
Perform Environmental Monitoring/Personnel Monitoring. Review and document results. Log information into appropriate database.
Perform Temperature Monitoring. Review and document results. Log information into appropriate database.
Perform pre- and post-sterilization Tissue Product Inspections and compare against the Product Specification Sheets to ensure compliance.
Perform inspections at each step of the final labeling and packaging process and ensure documentation is complete and accurate.
Obtain Tissue Retain Sample(s) for each final lot from distribution team and place in the appropriate area in the Tissue Retain Sample Storage Area. Ensure documentation is complete and accurate.
Complete all documentation prior to submitting to QA.
Log donors into all applicable databases. All databases/logs MUST be current at all times.
Prepare trends and graphs.
Maintaining and provide donor metrics to management.
Assist in creating/revising policies, procedures, specifications and forms for Donor Eligibility program.
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 21 CFR 1271 regulations.
Preferably CTBS or CEBT certified.
Experienced and proficient with Excel 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 P21/F1 21 P22
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.”