ndependently plan, prepare, coordinate, track, follow-up, and obtain clearances for medical device
submissions including, but are not limited to US, EU, Brazil, Russia, India, China, Japan, and other
countries.
? Represent Regulatory Affairs on assigned project teams through all phases of product
development, provide regulatory strategy, and assess regulatory impact of changes on existing
products.
Requirements: Bachelor's Degree (BA/BS) in Engineering or Life Sciences discipline required.
Minimum four (4) years of experience in Medical Devices or other health care regulated
industries required.
Experience with FDA, Health Canada, EU, Notified Body, and/or international regulators is
strongly preferred.
Experience with successful preparation, submission, and approval of US 510(k) and/or
international documents and registration and marketing of medical devices worldwide required.
Ability to clearly communicate and write reports and business correspondence in English.
Knowledge of Quality system Requirements and International Technical Standards.
This position is open to all candidates.
