Prepare and track paper and electronic submissions (e.g., 510(k), Technical Files). Coordinate regulatory documents, ensuring submissions are complete and filed. Research scientific and regulatory information in order to write, edit, and review reports. Compile all material required for submissions, license renewals, and annual registrations. Keep informed of professional and global regulatory information.
Bachelor’s Degree in a scientific discipline (Engineering preferred).
A minimum of 7 years of experience in Regulatory Affairs in Medical Devices.
Experience in Quality Control setting with FDA regulations and/or ISO standards (FDA’s CFR 21,
ISO 9001, ISO 13485) the European Medical Device Directive (93/42/EEC), and the Health
Canada Medical Device preferred
Strong background with class II products and 510k submissions
Proven ability to manage multiple projects in a matrix team environment.
Masters in Regulatory Affairs a plus.
Experience in directly interacting with Regulatory Agencies.
Ability to understand drawings and blueprints.
Ability to apply innovative solutions to moderately complex problems.
Knowledge of basic statistics.
Ability to communicate effectively with personnel at all levels both verbally and in writing.
Draft and maintain 510(k) documentation and submissions to the FDA and other regulatory authorities.
Supports Product Development and Quality team to ensure project outputs are compliant and ready for submission for market clearance or registration.
Responsible for regulatory assessment of design changes.
Registers the facility and devices manufactured for domestic and international distribution.
Responsible for proper handling of all product safety related complaints and any required
Reviews company literature/labeling and marketing material for regulatory compliance.
Support Field Corrective Actions such as Recalls, Field Safety Alerts, Market Withdraws and Stock
Recovery upon plan approval.
Maintains, reviews, and approves various company procedures to ensure regulatory compliance
with the QSR, ISO, Health Canada, and the European Medical Device Directive.
Conducts GMP, Health Canada, European Medical Device Directive, ISO 13485, and ISO 9001
training as required.
Monitors standards, regulations, and laws and alerts management and customers to proposed or
pending changes which may impact the Company's operations.
OrthoSensor, Inc., a world leader in Sensor-Assisted Total Knee Arthroplasty, develops and commercializes intelligent orthopaedic solutions with the goal of globally improving patient outcomes and satisfaction. Its leading product VERASENSE™ is a disposable sensor device which provides real-time intraoperative data, enabling surgeons to customize implant positioning and improve soft tissue balance... in primary and revision TKAs. The guiding vision of OrthoSensor® is to lead the global transformation of data-driven decision making in orthopaedic care to improve clinical and economic outcomes for healthcare stakeholders.