JOB PURPOSE AND SCOPE
· Responsible for the coordination and preparation of document packages for regulatory submissions.
· Monitors and improves tracking/control systems.
· Keeps abreast of regulatory procedures and changes.
· May direct interaction with regulatory agencies on defined matters.
· Ensures rapid and timely approval on medical devices and continued approved status of marketed medical devices.
· Ensures compliance with regulations and interpretations
CORE JOB RESPONSIBILITIES
· Compiles all materials required in submissions and license renewal.
· Coordinates and maintains reporting schedules for product licensing application notices.
· Interacts with regulatory agency personnel in order to expedite approval of pending applications.
· Compliance Work, procedures, employee trainings, promo materials, registration/approval etc.
MINIMUM SKILLS REQUIRED
· BSc Science/Engineering degree or higher
· At least 3 years prior experience related to regulatory affairs in a medical device company
· Working knowledge of the FDA Quality System Regulation 21CFR 820, 21CFR Part11, ISO13485, ISO14971 and the Medical Device Regulation MDR. And MDSAP program
· Organized with a high attention to detail
· Skill to conduct multiple tasks at the same time
· Communication skills
· Demonstrated scientific analysis abilities
· Excellent spoken and written of English and local language
· Job is Open for both man and women.