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.
Subject Matter Expert for one or more key QMS areas that Quality Engineering owns or supports (e.g., Process Validation, Equipment Program, Approved Supplier Program, Test Methods Validation, Design/Process Change Control, Control of Nonconforming Product, Design Controls, Production and Process Controls, Risk Management).
Lead Internal Audit program.
Assist or lead complaint handling activities (e.g., evaluation and investigation).
Assist or lead in the identification and implementation of CAPA.
Assist or lead Control of Nonconforming Product process activities (e.g., MRB review/approval).
Assist or lead with Risk Management activities and documentation (e.g., pFMEA).
Support new product development and production (e.g., Change Order review and approval).
Provide support necessary for supplier controls, including but not limited to, supplier audits.
Identify statistically based sampling plans for inspections and validations.
Aid in the implementation SPC control system with Manufacturing and Quality Control
Lead or support validations for new and existing products, processes and equipment.
Establish and maintain Quality Management System procedures related to areas of responsibilities.
Ensure compliance with FDA cGTP, AATB Standards, State regulations, and other applicable regulations/standards.
Participate in FDA inspections, AATB inspections and surveillance audits and customer audits.
Identify and implement opportunities for continuous improvement.
Collect and report metrics and data as required.
Prepare graphs and trends of quality records as needed.
Perform any other related duties as assigned and needed.
BS degree in Engineering, Math or Science (Biology, Chemistry, Physics, Statistics, etc.) or 7-10 years of working experience in Quality Assurance/Control
Minimum of five years’ experience in a regulated industry, preferably Human Tissue Transplant and/or Medical Device Industry
Certified Quality Engineer, preferred
AATB CTBS Certification, preferred
Working knowledge of QA Engineering related QMS elements including Design Controls, Production and Process Controls (including Process Validation), Control of Nonconforming Product, Facilities/Environmental Controls, Labeling and Packaging Controls, Handling, Storage, Packaging and Distribution of Product).
Strong Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).
Experience with measurement systems and statistical techniques.
Experience with auditing.
Experience with CAPA processes including investigational techniques.
Experience with Complaint Handling processes, especially investigations.
Experience with Risk Management regulations and application (ISO14971).
Working knowledge of FDA cGTPs
Working knowledge of AATB Standards and tissue banking regulations with applicable states, preferred
Ability to communicate effectively (both written and oral) using English (or local language).
Demonstrated ability to work cross-functionally in a team environment.
Ability to work independently with little supervision.
Familiar with the MS Office Suite, including Microsoft Visio and Project.
Must be able to observe company policies and safety procedures at all times.
Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.
Excellent communication skills, both written and verbal.
Excellent organization, prioritization and problem-solving skills
Able to lift 40 lbs
Internal Number: F1 21 P20
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.”