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Regulatory Affairs Project Manager

Location: San Jose, CA

Temperature Management


General Summary:


This position is located in San Jose, California


Responsible preparing US and International regulatory submissions/ product registrations for Class II and Class III medical devices.  Prepares 510(k), IDE, PMA, design dossiers and technical files, for US FDA and other international markets.  Interfaces with Regulatory Agencies, such as FDA, Notified Body and competent authorities as required.  Participates on new product development teams and develops regulatory strategies.  Maintains regulatory correspondence and submissions/registrations.  Willingness to perform other responsibilities as assigned.  Knowledge in US and international in medical device regulations.


Essential Functions:


·  Develops regulatory submissions [510(k), PMA, IDE, Annual/Periodic Reports] to US FDA, [Design Dossier, Technical Files and Notice of Change] EU notified body and other regulatory agencies.

·  Maintains European and international technical files/dossiers/registrations as required.

·  Participates in new product development teams, develops regulatory strategies, and provides regulatory support consistent with regulatory strategies.

·  Reviews and approves document change orders and engineering documentation (EDC).

·  Interfaces with Regulatory Agencies as required.

·  Prepares for facility registration, device listing, periodic reports etc. per U.S. FDA requirements and the requirements of foreign markets.

·  Maintains a list/database of product approvals/registrations.

·  Assembles Common Technical Document (CTD) and electronic filings for USFDA and other international regulatory agencies.

·  Ensures continuous update and maintenance of the Regulatory Affairs documentation.

·  Manages and coordinates company activities to ensure the timely submission and approval of applications, amendments, supplements, and other regulatory correspondence.

·  Interprets, executes and recommends modification to internal guidelines, work instructions, and procedures related to regulatory affairs.

·  Monitors industry and regulatory trends and develop strategy and provide guidance related to such trends.

·  Interacts with appropriate departments to obtain required information for regulatory submissions and correspondence.

·  Tracks the status of regulatory submissions during submission development and review/approval progress and communicates to management.

·  Corresponds with cross-functional teams and individuals, and external agencies as required.

·  Assists on other projects and tasks as required.

·  Be able to work with minimum supervision

·  Be self-motivated and be able to read and follow procedures


Education/Training/Experience Requirements:


·  Bachelor’s  degree in Life Sciences or Engineering
·  Minimum 7 years medical device regulatory affairs experience with USFDA and international submissions
·  Strong knowledge of US and international submission requirements and US and International regulations.
·  Ability to work independently and as part of a team.
·  Demonstrated ability to work with minimal supervision on multiple concurrent tasks/activities and meet corporate strategies and goals.
·  Excellent computer skills, knowledge of Microsoft Office package, Windows and e-mail systems
·  Excellent verbal and written communication skills and the ability to work with all levels within the Company, international distributors, and regulatory agencies
·  Strong organizational skills and attention to detail