What are the responsibilities and job description for the RA/QA Specialist position at Akesis, Inc.?
Job Description
Description
The RAQA Specialist manages, coordinates, and documents regulatory processes, including inspections, audits, and registrations. This core member of the RAQA team assists in obtaining and maintaining government approval to bring our AI technologies to market.
Essential Duties -
· Prepare or coordinate the preparation of pre-submissions, de novo requests, 510(k) submissions, and technical files for CE marking.
· Participate on project teams, providing regulatory strategy, timelines, and deliverables.
· Work collaboratively with company engineers, providing informed, creative, and effective solutions to the challenges the design team faces in getting products through to commercial release.
· Review change orders and assess regulatory impact of product changes on US, EU and/or international regulatory strategy and submissions per standard procedure.
· Review labeling and assess compliance against relevant regulations and product requirements.
· Interpret statutes, regulations, policies, and guidance, communicating how these impact product development, manufacturing, and/or marketing.
· Develop and maintain regulatory affairs department procedures and process improvements.
· Perform other duties as assigned.
Qualifications -
· Excellent technical writing and communications skills with a highly analytical, detail-oriented approach to solving complex problems
· Strong planning and organizational skills
· Strong teamwork ethic, passion for learning, and desire to seek new challenges
· Proficient with Microsoft 365 or similar software