Regulatory Affairs Specialist (Medical Device)

  • Anywhere

Company :

Location :
Fremont, California

Expiry Date :
Fri, 05 Feb 2021 23:59:59 GMT

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Description :
Are you interested in working with the largest independent software testing company? Read on!

QualiTest is looking for a Regulatory Affairs Specialist in Fremont, CA to join our rapidly expanding teams!

* Assure regulatory compliance with internal procedures and external standards.
* Spearhead Unique Device Identifier (UDI) activities for companywide implementation.
* Provide regulatory support on product development teams through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)
* Provide regulatory assessments for manufacturing, design changes, and validation activities
* Provide regulatory input in quality system assessments, product development, and complaint/MDR/Vigilance handling system.
* Review and approve test protocols to support regulatory submissions.
* Support the Think Quality Policy and Quality Management System.
* Provide input and reviews Design Control documentation such as: Risk Management, Design verification, design validation, shelf life studies, pre-clinical studies, and clinical studies.
* Identify guidance documents, international standards and consensus standards, and risks and assist product development teams with their interpretation.
* Review and approve product labeling, claims, training materials and advertising/promotional materials.
* Track and maintain regulatory registrations and product blocking lists to ensure valid international regulatory clearances, sales, and commerce implications.
* Perform vigilance activities
* Assist in negotiations with the FDA or other regulatory agencies.
* Maintain regulatory affairs product files to support compliance with regulatory requirements.
* Review domestic and international Marketing Advertising and Promotional materials to ensure valid label claims are consistent with US and international rules and regulations.
* Handle FDA customs import/export requests, customer service needs, and other requests from internal customers
* Develop, document, and implement a regulatory strategy plan to support product development and company goals
* Provide continual regulatory updates to the Management Team to ensure that processes needed for the quality system regulation are established, implemented and maintained.
* Establish and maintain regulatory information systems both electronically and hard copy.
* Responsible for Medical Device Directive.
* Serves as communicator with all regulatory agencies for both oral and written communications and reporting, ensuring reports are compiled, approved, and distributed to appropriate internal personnel as well as external agencies. Also manages the preparation and quality check of all regulatory submissions to regulatory agencies.


* Awareness of international regulatory requirements and quality systems.
* 3+ years Regulatory Affairs medical device industry experience.
* 510(k) experience required, IDE, PMA – optional -(original/revision/supplements) preparation, submission and clearance/approval
* Proficient in 21 CFR 820 and the Medical Device Directive, international a plus
* Direct interaction with FDA reviewers/inspectors
* Working knowledge of ISO 13485 and CE mark requirements.
* Experience with medical device software in conformance with IEC 62304
* Working knowledge of MDR Reporting
* Team based work environment experience preferred with leadership of teams
* Strong interpersonal, written, oral, communication, organizational and planning skills Working knowledge of personal computer systems and desktop office applications
* Sound understanding of scientific principles
* Able to work on a team.
* Ability to work independently and under minimal supervision.
* Must be able to work in a timeline-driven environment.
* 4 year degree in scientific area; RAC certification desired
* Knowledge of good manufacturing practices (GMP) and applicable Quality System Standards.


Why QualiTest?

* Have continuous access to and work with Senior Testing Specialists and Practice Experts
* Be a part of a leading testing company, globally recognized as a Visionary by Gartner Magic Quadrant
* Work with cutting edge technology in a company built by testers for testers, this is what we do!
* As a global company, we offer unique placement opportunities around the world
* Our QualiTesters are the reason for our success, we constantly encourage career development and promote from within

Intrigued to find more about us?

* Visit our website at [
* Check out our Career page: [

If you like what you have read, send us your resume and lets start talking!