Regulatory Affairs Specialist InfraReDx
Ensure all company products meet worldwide regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance.
Responsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA), European Union, and Asia Pacific regulations/interpretations. This may include the review, evaluation, and compilation of files and reports for submissions.
Provide project team representation and direction in managing information from/to other departments (including Product Development, Manufacturing, Quality, Marketing, and Clinical Affairs) regarding Regulatory submissions. This may included the preparation of outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments.
Review technical and clinical documentation and recommend changes for labeling, manufacturing, and clinical protocol for regulatory compliance.
Research and analyze regulatory information and determine acceptability of data, procedures, and other product-related documentation presented in support of product registration.
Responsible for the timely completion of regulatory projects and submission of documentation, both internal and external.
Develop and maintain current regulatory knowledge and keeps abreast of regulatory procedures and changes.
Provide regulatory guidance to project teams.
Bachelor?s degree required preferably in the life sciences; advanced degree a plus
At least 5 years of experience in medical device field, including hands-on experience with OUS submissions.
Experience with software driven medical devices a must.
In depth knowledge of FDA laws and regulations.
Strong knowledge of international regulatory pathways and requirements, i.e. CE Mark Technical Files and Design Dossiers, as well as Japanese Shonin submissions.
Team player with ability to work independently.
Excellent and effective written and verbal communication skills.
Excellent interpersonal skills, good judgment and analytical skills.
Effective time management and organizational skills.
Consistent, quality work and follows through on commitments.
Fluency in written and spoken English.
Travel ? up to 10% travel.
||34 Third Avenue |
Burlington, MA 01803