Key participant in the effort to demonstrate regulatory and quality compliance; to enhance efficiency and productivity in completing tasks and managing projects; prepare and maintain assigned required documentation.
Description of Duties/Qualifications
Execute and manage product registrations for USFDA submission (510(k), CE-mark certificate and other international registrations, which includes creating and maintaining Technical Files and supportive documents.
Work with and lead multi-departmental teams to implement regulatory strategies and provide regulatory-impact-analysis (RIA) in accordance with regulatory requirements and ConMed's policies and procedures.
Review and approve engineering change notices and project plans to assure appropriate regulatory requirements are met.
Monitor and decipher the regulatory environment; provide appropriate notifications and information to International Divisions and distributors for the registration of products with foreign regulatory agencies.
Project management; prepares action plans for implementation; daily multi-tasking.
Provide timely review and approval of product labeling for regulatory compliance.
Other specific projects as identified and required by the Department Manager.
Encourage cross-functional interface to share regulatory intelligence and generate solutions effectively.
Over 3 years up to and including 5 years in a regulatory and or quality environment.
Bachelor degree in technical discipline/engineering or business.
Multi-language a plus.
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