Regulatory Specialist

The Regulatory Affairs Specialist is responsible for providing regulatory support and applies professional regulatory practices for product line to meet established project quality, regulatory and financial objectives and serve as Regulatory Affairs Specialist, whose primary function is:

· Responsible for managing, coordinating, and documenting internal regulatory processes, which may include inspections, internal audits, license renewals, registrations, and several other processes under certain regulations.

· Assisting in obtaining and maintaining government approval for medical devices

· Responsible for collecting, gathering, compiling, and preparing the materials needed for registration and submission to regulatory agencies.

· Strategically achieve and maintain a balance between regulatory concerns, marketing objectives, time to market, technology, compliance, and costs.

· Understand and be familiar with all aspects of product development, which may include clinical trials, research, manufacturing practices, regulations, and approval processes.

· Knowledge with 510K and CE submissions

Position Requirements:

· A minimum of a Bachelor's Degree in Business, Science Related Field or Engineering is required. An advanced degree and/or MBA are a plus.

· A minimum of 1 year of broad-based technical/engineering/quality expertise in the medical device or pharmaceutical industry is required.

· Proficiency with engineering analysis and statistical software is an asset.

· Flexible and adaptable, capacity to work in a fast pace learning and complex environment is a must.

· Working knowledge of Medical Device Regulations, Directives and Applicable standards in the areas of Quality Systems and Vigilance is required.

· Knowledge of practices and policies of regulatory agencies required. Initiative in innovative approaches to Quality and Regulatory solutions and applications in a fast paced changing business environment.