We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and the largest corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, medical mobile apps, in vitro diagnostics and more.
We are seeking an accomplished Regulatory Affairs Associate to assist our senior Regulatory staff with U.S. and international strategies, submissions, and reporting/compliance activities. We are looking for a technically strong, self-directed and collaborative individual to work within our organization and in a variety of client settings per project dictates. This Regulatory Affairs Associate will report to a Vice President of Regulatory and must be able to collaborate with our Regulatory, Quality and Clinical staff as well as work independently on appropriate level tasks.
MAJOR DUTIES OF POSITION:
KNOWLEDGE AND SKILL REQUIREMENTS
The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.
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