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Regulatory Affairs and Quality Assurance Manager

Company: PEAK Technical Staffing USA
Location: Pleasanton
Posted on: January 8, 2022

Job Description:

Regulatory Affairs and Quality Assurance Manager Pleasanton , CA 94566 Posted: 09/27/2021 Employment Type: Direct Placement Category: Quality Job Number: 91398 Job Description
PEAK is looking for a Regulatory Affairs and Quality Assurance Manager for a client in Pleasanton, CA. This is direct/full time opportunity with competitive pay, bonus, and benefits based on experience.

The Regulatory Affairs and Corporate Quality role is responsible for providing strategic guidance and leadership regarding device registration in new markets, regulatory pathway for new products, maintaining compliance with applicable regulations, and updating management with changes to regulations and laws. This role is responsible for interacting with regulatory bodies such as FDA, European Union Notified Bodies, MNPA, ARTG, etc. This role will serve as the Management Representative during external audits and oversee the internal audit process

The Regulatory Affairs and Corporate Quality role will administer and improve Corporate Quality policy including by not limited to the change control, design control, corrective and preventative action process, management reviews, and analysis of performance indicators for trends indicating a loss of product quality. This position shall be responsible for maintaining, implementing, and establishing systems to assure product quality and compliance to FDA guidance, 21CFR part 820, CGMP, ISO[1]13485: 2016 and similar applicable standards. The successful candidate will be a teammate that will provide critical review of documents, create learning opportunities, and enable innovation through their cooperative behavior. This role will maintain the responsibility of maintaining the technical files required for global regulatory approvals, and support transfer activities of new designs from Engineering to our Operations group.


  • Exhibit and promote data driven decision making consistent with compliance to best practices and consistent with regulatory requirements such as 21 CFR 820, ISO 13485, ISO 14971, MDR, and other appropriate guidance
  • Management Representative within the company for any and all quality affairs matters, internal or external compliance inquiries, and including all planned and unplanned audits by domestic or foreign authorities.
  • Establish and maintain relationship with FDA, Authorized Representative, Notified Bodies, and similar agencies regarding maintaining or establishing market access for the product portfolio
  • Stay current and well versed in 21 CFR 820 and able to articulate the key regulation to management with examples.
  • Exhibit responsibility for the quality management system, educate and nurture quality practices to maintain the reliability of products.
  • Enhance quality performance and capabilities through early involvement with operations and engineering departments.
  • Provide guidance and mentorship to Operations, Engineering, Service, and Management departments have access to the tools and skillsets needed to foster quality practices throughout the organization
  • Provide day to day support to both internal and external customers for all Regulatory and Quality concerns
  • Other duties & responsibilities as assigned
    • Bachelor' s degree in Science, Math or Engineering.
    • 5 or more progressive years of work experience in Regulatory Affairs
    • Comprehensive knowledge of medical device regulations such as 21CFR820, Medical Device Regulation, In-Vitro Diagnostic Device Directive, etc.
    • Regulatory pre-market communication such as FDA pre-submission meeting request and preparing 510(k) submissions
    • Post market communication and reporting to regulatory agencies
    • Post Market Surveillance system implementation
    • Authorship of verification or validation protocols
    • Excellent written communication skills
    • Excellent oral communication skills
    • Quality System implementation
    • Design Controls
    • Document Control
    • Must be able to work in Pleasanton, California without relocation assistance.
      • Graduate degree in Science, Math or Engineering
      • 10 years of experience in a related regulated medical device environment
      • Experience with respiratory or PFT equipment.
      • Experience with Class II diagnostic devices
      • Experience in consumer products.
      • Accredited certification in Regulatory Affairs
      • Experience building compliant QMS for and successful certification to MDSAP and MDR Login to save this search and get notified of similar positions. Related Jobs:
        • Regulatory Specialist
          San Jose, CA Login to save this search and get notified of similar positions. Take control of your career! Join the team as a recruiter at PEAK and build the future of your dreams.

Keywords: PEAK Technical Staffing USA, Pleasanton , Regulatory Affairs and Quality Assurance Manager, Executive , Pleasanton, California

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