Regulatory Associate

Responsibilities

• Enters and maintains registration data in database(s) and dashboard(s).
• Audits registration data in applicable systems to ensure data is current and correct.
• Supports the creation of technical and other documentation for international regulatory submissions (new and renewals) according to applicable standards/regulations.
• Supports various labeling programs/updates, changes to regulatory-owned documents within document control systems, updates to other documentation (e.g., IFUs), data searches compilation (e.g., for clinical evaluation), and Regulatory review of Change Notices to determine notification to international regulatory agencies.
• Supports audits by third parties (FDA, BSI, and Others) as required.
• Maintains other records, databases, systems as needed in support of regulatory activities (e.g., consensus standards, journal articles, contracts, purchase orders).
• Supports administrative regulatory tasks such as consolidation of multiple documents into a single document, bookmarking relevant sections, preparation for e-submission, etc.
• Collaborates in coordinating signatures of various documents for international submission.
• Conducts various administrative duties for the International RA team including POs, meeting coordination, etc.

Qualifications

• Bachelor’s degree in science, health, or technical discipline.
• Relevant experience may be considered in lieu of educational background.
• 0 - 2 years of medical device regulatory experience.
• Computer/technical proficiency including experience with MS Office and working knowledge of Adobe, SAP, Windchill and other software as needed.
• Knowledge of applicable EU and/or other region-specific medical device regulations, requirements and standards preferred.
• Experience with quality and document control systems in a regulated space preferred.
• Ability to work well with others, manage multiple projects simultaneously, and follow directions.
• Excellent attention to detail and verbal and written communication skills.
• Ability to read and speak English sufficiently to read, understand and complete all documentation.