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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
European Union Regulatory Affairs, Medical Device, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
At Inova, the RA Specialist reports into the RA Manager. The RA Specialist is responsible for preparing technical files and communicating appropriate information to fulfill requirements in support of international product registrations.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Create and maintain CE technical files.
Prepare, collect or coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners.
Communicate with and fulfill requests in response to needed documentation to support international regulatory registrations.
Reviews design history files, device history records and documentation associated with the development and/or enhancement of product, or requests from appropriate department as needed additional technical documentation, to create/maintain Technical Files and support regulatory filings and CE mark submissions and updates.
Create and maintain regulatory database.
Bachelor's degree in a Life Science with 3 years of experience in Regulatory Affairs, preferably in the medical device/in vitro diagnostics industry. Experience with U.S. Class II medical device is a plus.
Background / Skills / Knowledge
Experienced in creating and maintaining CE Technical File is essential.
Experience with international registrations is a plus
Working knowledge of ISO 13485 and Quality System Regulations.
Verbal and written communication utilizing critical thinking, problem solving skills and organizational talents is required.
Additional Salary Information: Salary based on experience
Inova Diagnostics, Inc., part of the WerfenLife, SA, is a worldwide leader in the development and manufacture of in vitro autoimmune disease diagnostic reagent products. We are dedicated exclusively to advancing the state-of-the-art in autoimmune disease diagnostics, which has gained us recognition from leading physicians and medical institutions around the world for our cutting-edge products and ...customer service. Our focus on autoimmune disease diagnosis has allowed us to offer the highest product quality, reliability and consistency to our customers. Our commitment to industry leadership and quality creates a unique and highly challenging work environment that rewards dedicated individuals whom desire to be part of a winning team. Our employees enjoy competitive salaries; position-specific training; family-friendly work hours and an open, welcoming work environment. We offer above-average benefits, including; comprehensive medical, vision, dental and life insurance benefits, with FSA and Section 125 plans, and a 401K plan with employer contributions, as well as a tuition assistance program.