Description Essential Job Duties and Responsibilities: * Organize, update, and maintain regulatory documentation in accordance with company policy and procedures. * Assist in audit preparation when needed. * Support review and maintenance of product labeling. * Aid in the completion of the following tasks: * Assist with the preparation of regulatory submissions globally. * Initiation, collection, and coordination of information for regulatory documents for various purposes. * Coordination with global/local RA counterparts to obtain product approvals and renewals. * Conduct research about new regulations and guidance documents. * Develop and review corporate and department procedures. * Begin to be able to analyze and understand regulatory requirements and identify solutions; provide possible suggestions for implementation. * Ensures accurate population of databases for tracking global product registrations.

Knowledge, Skills, and Abilities: * Ability to work effectively with multiple disciplines and personalities. * Self-starter starter, with the ability to work and learn independently. * Demonstrate initiative and can work both independently and collaboratively in a team structure. * Strong attention to quality/detail. * Strong interpersonal and communication skills (written and verbal). * Ability to handle multiple tasks and priorities. * Proficient with computer and standard software programs (Microsoft Office, Adobe Pro). * Excellent organizational, time management, and administrative skills.

Training and Education: Bachelor's degree or equivalent.  Science background preferred.

Experience: 1+ years in regulatory affairs or equivalent.  Medical device/IVD industry preferred.