Katalyst CRO
Overview
The position focuses on regulatory submissions to market medical devices in the U.S. and Europe, support of international product registrations, and related regulatory affairs activities. Responsibilities include ensuring the product development process addresses applicable regulatory requirements and business objectives, with attention to data analysis, problem solving, and detail orientation. Responsibilities
Prepare regulatory submissions required to market medical devices in the U.S. and Europe. Support international product registrations, including new registrations, re-registrations, and product change registrations/notifications. Represent Regulatory Affairs on project teams by providing regulatory guidance throughout the product development cycle, coordinate inputs for regulatory submissions, and review and approve applicable design control documentation. Coordinate and collect registration information with R&D, Quality, Medical, Manufacturing, etc. Assess necessity for submitting a 510(k) application for proposed device changes and prepare internal Non-Filing Justifications for changes that do not require a 510(k) submission. Prepare/update technical files for CE marking with input from various functions (R&D, Quality, Medical, Manufacturing, etc.). Submit notifications to the EU Notified Body for significant changes to CE-marked products. Maintain Regulatory documentation and support special projects as needed. Requirements
B.S. degree or higher in a life science or technical discipline (engineering, bioengineering, biology, or chemistry preferred). 2-5 years of Medical Device experience. Working knowledge of industry consensus standards and FDA guidance. At least 2 years of Regulatory Affairs experience in Medical Device regulations. Demonstrated success in taking products through FDA and EU Notified Bodies. Working knowledge of 510(k), MDD 93/42/EEC. Regulatory Affairs Certification (RAC) preferred. Proficient in Microsoft Office. Strong communication and project management skills; ability to handle multiple tasks with attention to detail. Knowledge of 21 CFR 820 and ISO 13485; familiarity with relevant medical device standards and FDA guidance. Senior
Seniority level: Associate Employment type
Contract Job function
Legal Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
The position focuses on regulatory submissions to market medical devices in the U.S. and Europe, support of international product registrations, and related regulatory affairs activities. Responsibilities include ensuring the product development process addresses applicable regulatory requirements and business objectives, with attention to data analysis, problem solving, and detail orientation. Responsibilities
Prepare regulatory submissions required to market medical devices in the U.S. and Europe. Support international product registrations, including new registrations, re-registrations, and product change registrations/notifications. Represent Regulatory Affairs on project teams by providing regulatory guidance throughout the product development cycle, coordinate inputs for regulatory submissions, and review and approve applicable design control documentation. Coordinate and collect registration information with R&D, Quality, Medical, Manufacturing, etc. Assess necessity for submitting a 510(k) application for proposed device changes and prepare internal Non-Filing Justifications for changes that do not require a 510(k) submission. Prepare/update technical files for CE marking with input from various functions (R&D, Quality, Medical, Manufacturing, etc.). Submit notifications to the EU Notified Body for significant changes to CE-marked products. Maintain Regulatory documentation and support special projects as needed. Requirements
B.S. degree or higher in a life science or technical discipline (engineering, bioengineering, biology, or chemistry preferred). 2-5 years of Medical Device experience. Working knowledge of industry consensus standards and FDA guidance. At least 2 years of Regulatory Affairs experience in Medical Device regulations. Demonstrated success in taking products through FDA and EU Notified Bodies. Working knowledge of 510(k), MDD 93/42/EEC. Regulatory Affairs Certification (RAC) preferred. Proficient in Microsoft Office. Strong communication and project management skills; ability to handle multiple tasks with attention to detail. Knowledge of 21 CFR 820 and ISO 13485; familiarity with relevant medical device standards and FDA guidance. Senior
Seniority level: Associate Employment type
Contract Job function
Legal Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr