Job Description Summary
This position isresponsible for the preparation of regulatory submissionsrequired to market new or modifiedmedical devices in both the U.S. and Europe, and related regulatory affairsactivities, such as development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business.
Coordinate, prepare, and follow up with FDA Premarket Notification [510(k)] submissions in a timely manner. Act as liaison with FDA regarding product clearance. Assess necessity for submitting a 510(k) application for proposed device changes.
Prepare internal “Non-Filing Justifications” (U.S.) for changes that do not require a 510(k) submission. Prepare technical files for CE marking with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner. Submit notification to the Notified Body about significant changes to CE marked products in a timely manner.
Represent RA in design teams and projects by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions. Support International Regulatory Associates as it pertains to registering our devices worldwide.
Review/approve label/labeling, promotional and advertising materials to ensure regulatory compliance. Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.
Represent RA in product life cycle development teams by reviewing, approving, and completing requirements. Submit product listing to the FDA when deemed necessary. Request FOI information and maintain FOI files. Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis. Coordinate and respond to requests for product data/information, surveys/questionnaires requested by customers.
B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry
- At least 5 years of experience with medical device regulations is required
- At least 2 years of experience with devices containing software or drug-device combination products is preferred.
- Human factors and usability engineeringexperience is preferred.
- Understanding of regulatory frameworks, and the ability to interpret and apply new or emerging regulations.
- Strong organizational and written/verbal communication
- Attention to detail
- Demonstrated problem solving abilities
- Self-motivated with the ability to effectively manage and prioritize multiple complex tasks
Job ID R-24779