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About Anchor Technical Services:
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Full service technical staffing firm specializing in the following:
IT
Engineering
Scientific
Communications
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For details about Anchor Technical Services, click here.
About the Opportunity/Requirements:
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Responsible for the preparation of regulatory affairs submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This responsibility entails development , execution, and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business
Candidate must be able to understand and interpret U.S. and International medical device and in vitro diagnostic device regulatory requirements; provides guidance on requirements to product teams.
Develops strategies for submissions necessary for new product market clearance/approval and product continuance: 510ks, PMA and supplements, IDEs
Prepares and/or compiles information required by ex-U.S. regulatory associates to register or license products outside the U.S.
Interacts and negotiates with U.S. regulatory agencies
Coordinates the preparation of additional data/information requested by regulatory agencies and prepares appropriate responses to all such requests.
Participates in the development and review of product release documents
Reviews labels, labeling, and promotional materials for compliance with applicable regulations and policies.
Provides regulatory opinions in premarket regulatory requirements, export, and labeling requirements.
B.S. Degree in the Biological Sciences, Chemistry, or related science required.
Minimum of 3 years experience in the device/diagnostic, biologic, and/or pharmaceutical industry, primarily in the area of regulatory affairs or working with molecular instrumented products.
Current knowledge of U.S. medical device and in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP), and Quality System Regulations (QSR); current knowledge of European Medical Device and IVD Directive requirements and European quality system standards.
Knowledge of Canadian and Japanese device regulations desired.
Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.
Ability to organize work; project management experience desirable.
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