Regulatory Affairs and Quality Assurance Director

1 week ago

Redwood City, California, United States Pulmonx Full time
Job Summary

The Vice President, Regulatory Affairs and Quality Assurance will lead the development and implementation of regulatory strategies worldwide to ensure compliance with quality regulations and standards. This role will oversee the preparation of regulatory submissions, manage global licensing and product registration, and interact with regulatory authorities worldwide.

Key Responsibilities
  • Regulatory Strategy and Compliance
    • Develop and implement regulatory strategies to ensure compliance with quality regulations and standards.
    • Oversee the preparation of regulatory submissions, including technical and scientific documents and dossiers.
    • Manage global licensing and product registration of new products and enhancements to existing approved products.
  • Regulatory Team Management
    • Direct activities of the Regulatory team at Pulmonx headquarters.
    • Act as a liaison to the FDA and ensure timely responses to regulatory agency inquiries.
  • Quality Assurance and Compliance
    • Oversee the Quality Assurance team during facility inspections and audits of the Pulmonx Quality System.
    • Direct and oversee the Pulmonx Customer Experience Reporting system, including product investigations and evaluation of each reported event for regulatory reporting.
  • Regulatory Guidance and Support
    • Provide regulatory guidance and support to Pulmonx R&D teams for new or enhanced projects.
    • Provide guidance and support to Clinical Affairs teams with respect to clinical studies involving Pulmonx products.
  • Regulatory Environment and Compliance
    • Assess and communicate to Pulmonx management changes in the domestic and global regulatory environment that may impact customers, Pulmonx products, and Pulmonx operations.
    • Collaborate with senior managers to establish and implement company policies to assure ongoing compliance with regulatory requirements.
  • Regulatory Communication and Education
    • Educate external customers (e.g. clinical sites) regarding regulatory compliance.
    • Maintain good working relationships with regulatory agency representatives and in-country representatives/distributors.
  • Regulatory Leadership
    • Act as Person Responsible for Regulatory Compliance (PRRC) under the EU Medical Device Regulations.
    • Stay abreast of quality and regulatory requirements for the U.S. and the major international markets.
Requirements
  • Education
    • Bachelor's Degree required, preferably related to Regulatory Affairs, Quality Assurance, Life Sciences, Legal, and/or Engineering disciplines.
    • MS a plus.
  • Experience
    • Minimum of 12 years' experience in advanced medical device RA/QA is required, with at least 5 years management experience therein.
    • Experience with Class III and Class II medical devices and implantable products desired.
  • Skills
    • Strong negotiating skills and an ability to ensure that Pulmonx will pursue full compliance with all applicable regulatory and quality guidelines.
    • Excellent written, verbal, and interpersonal communication skills.
    • Ability to travel as required to effectively perform all functions of the position.

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