Vice President, Regulatory Affairs & Quality Assurance

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Vice President, Regulatory Affairs & Quality Assurance

The Vice President, Regulatory Affairs and Quality Assurance implements regulatory strategies worldwide to 1) ensure that regulatory requirements are met, and 2) obtain regulatory approval for Pulmonx products. The VP oversees compliance to quality regulations and standards. The VP oversees the preparation of regulatory submissions intended for regulatory agencies worldwide and manages global licensing and product registration of new products and enhancements to existing, approved products. These specific activities require interaction with regulatory authorities worldwide both directly and through in-country representatives.
Responsibilities and Capabilities
Define and lead the Regulatory and Quality strategies for the company, including Regulatory submissions, product development and registration activities, post-market surveillance, Quality Management Systems, audits.
Act as a liaison to the FDA and ensure timely responses to regulatory agency inquiries.
Direct activities of Regulatory team at Pulmonx headquarters during preparation of technical and scientific documents and dossiers intended for review by regulatory authorities.
Direct and oversee the Pulmonx Customer Experience Reporting (i.e. Complaint Handling) system, including product investigations and evaluation of each reported event for regulatory reporting pursuant to – but not limited to – the Medical Device Reporting, Vigilance Reporting and Mandatory Reporting regulations of the U.S., European Union, Canada and emerging market countries.
Provide regulatory guidance and support to Pulmonx R&D teams for new or enhanced projects and provide guidance and support to Clinical Affairs teams with respect to clinical studies involving Pulmonx products.
Oversee the Quality Assurance team during facility inspections and audits of the Pulmonx Quality System.
Lead all ancillary regulatory functions (e.g. promotional material review, labeling, etc.) for the expressed proposed of delivering timely and cost-effective services to internal customers.
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.
Educate external customers (e.g. clinical sites) regarding regulatory compliance.
Maintain good working relationships with regulatory agency representatives and in-country representatives/distributors in order to facilitate timely review and approval of Pulmonx products.
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.
Other tasks as assigned, including but not limited to marketing review, compliance matters, clinical trial strategy, etc.
Requirements
Bachelor's Degree required, preferably related to Regulatory Affairs, Quality Assurance, Life Sciences, Legal and/or Engineering disciplines. MS a plus.
Regulatory Affairs (R.A.C.) credential is strongly desired.
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.
Strong negotiating skills and an ability to ensure that Pulmonx will pursue full compliance with all applicable regulatory and quality guidelines.
A “hands-on” approach to achieving and producing expected results, and therefore includes proficiency at using industry-standard PC software programs including database systems as tools.
Excellent written, verbal, and interpersonal communication skills.
Must be available to travel as required to effectively perform all functions of the position.
Compensation:

$250,000 - $350,000
Please note that an application and resume must be completed and submitted for consideration for this opportunity.
Pulmonx Corporation is an Equal Opportunity Employer and embraces diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any characteristic protected by applicable law.

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