Position Summary and Overview of RA Officer role
This is a professional position with responsibilities for supporting tasks associated with the site regulatory obligations.
Will follow existing policies, procedures and work instructions to plan and conduct tasks. Will receive instruction and guidance from manager(s) or Sr.
RA Officer / Specialist(s). The entry level RA Officer / Specialist will minimally have a college or university degree in science (or equivalent), and the ability perform routine tasks.
With additional experience, the RA Officer / Specialist will work more independently and expected to apply experience to more complex tasks and problems.
o Support the review and analysis of product complaints, clinical reports and other data against established processes and procedures.
o Support and organize safety and filing decisions for in collaboration with Sr. RA Officer(s), RA management.
o Support and organize the review and approval of labeling, advertising and promotion for compliance to applicable regulations
o Support Sr. RA Officer(s), RA management in the implementation of new regulations.
o Work with global colleagues in support of product registrations and submissions.
o Establish and maintain official site regulatory files according to government expectations and company procedures
o Serve as site RA representative on new product development teams and change management initiatives
o Establish and maintain device listings and licenses according to government requirements
o Support the documentation of regulatory strategies
Required Skills / Experience / Education
Relevant certifications preferred.
o Experience with regulatory submissions and registrations
o Experience with regulatory affairs
o Experience with regulatory compliance