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RA Specialist IV- Project Manager
Ref No.: 18-13501
Location: Milpitas, California
Start Date: 10/10/2018
The primary responsibility of this individual is to provide independent regulatory guidance to new product development and Value Stream teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches including defining data and information needed for regulatory approvals in conjunction with cross-functional business partners
Under limited supervision, S/he will be responsible for providing regulatory guidance to project teams and will be responsible for assessing device/manufacturing changes, developing regulatory strategies and writing/coordinating/compiling and submitting regulatory documents to FDA and other Regulatory Agencies.

Documents to include PMAs, PMA Supplements/ Amendments/Annual Reports, 510(k)s, IDEs, Change Notifications,Technical Files/Design Dossiers (CE Mark) and responses to regulatory agencies' questions and other correspondence.

This individual will act as regulatory liaison to U.S. Food & Drug Administration for Annual Reports and other regulatory submissions.

The position requires extensive collaboration with colleagues in other functions to ensure team objectives and milestones are met in a timely manner. Ensures compliance with regulatory agency regulations and interpretations. Develops timelines for submissions under the direction of senior regulatory affairs staff. Develops solutions to a variety of problems of high scope and complexity.

Participates in the development, review and approval of product labeling.
Perform other duties as assigned by the manager of this position.

Minimum education required for competent performance:
Bachelor's Degree or equivalent
Minimum of 6-8 years related work experience
Equipment usage and abilities needed:
Proper application of Title 21 of the US Code of Federal Regulations
Proper application of Part 800-1299 (21 CFR 800-1299)
Proper application of US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k)
Proper application of European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC)
Proper application of Quality Management System Standard ISO 13485
Proper application of Risk Management Standard ISO 14971
International Medical Device requirements (China, Japan, Canada, Australia, Brazil, Russia, etc.)
Excellent written and oral communication skills.
Good analytical thinking, problem solving and investigative skills.
Proficiency in Microsoft Office and all related applications