Pulmonx Corporation, based in Redwood City, CA, is focused on developing and marketing minimally invasive medical devices and technologies for the diagnosis and treatment of pulmonary disorders. For its Redwood City location it is seeking a Vice President, Clinical Affairs and Regulatory Compliance.
Responsibilities and Capabilities:
Plan, develop and implement policies, procedures, practice and strategy for the Clinical Research and Regulatory Affairs functions.
- Participate as an active member of the senior management team to ensure the activity of CA/RA is in support of the strategic direction and objectives of the company
- Develop and successfully execute global clinical and regulatory strategies and implementation plans to ensure product approval while meeting corporate objectives within applicable regulations and guidelines
- Provide leadership for US and international regulatory affairs including the preparation, submission, and maintenance of facility and product licenses/registrations (e.g., FDA PMA and 510(k), EU CE Mark, and Canada MDL) and ensuring compliance with incident and field correction reporting regulations (e.g., FDA MDR, EU Vigilance)
- Provide leadership for US clinical operations including developing clinical research strategies, applying for and obtaining government (e.g., FDA IDE, HDE) and institutional (e.g., IRB) approvals for clinical research studies, conducting clinical research studies in accordance with government regulations and Good Clinical Practice, ensuring timely recruitment and quality data collection, and reporting on results of clinical research
- Develop clinical research recruitment and retention strategies, including appropriate types of advertisement, patient enrollment drivers, and site motivation tools. Work with study centers to ensure that enrollment targets are met on time and within budget.
- Develop and maintain professional and credible relationships with key opinion leaders, medical directors, regulatory officials, investors, consultants, vendors, and co-workers.
- Participate in the short and long range planning of new product opportunities.
- Plan, schedule, and complete projects in an aggressive manner consistent with corporate objectives.
- Regularly make presentations to senior management.
- Develop and manage departmental budgets.
- Procure and oversee outside vendors and consultants as required.
- Actively work to promote team building and morale within the department.
- Perform other duties as assigned.
Bachelor’s Degree in engineering or life sciences or equivalent experience required. Background in epidemiology, biostatistics or advanced degree is a plus.
Minimum fifteen years related clinical and compliance experience in the medical device industry (Class III, PMA devices strongly preferred) in addition to at least five years management experience.
Prior experience in direct interaction with regulatory agencies including managing meetings and agency correspondence, especially FDA.
Experience in clinical research including statistical competence and ability to extract and present key data elements from clinical studies that support safety and effectiveness in a concise, compelling manner.
If you are interested in joining our team and believe you possess the necessary experience and skills, please submit your resume and cover letter to the following address:
- The person will be expected to follow and support all Company policies and procedures
- The person must ensure their activities and those of their staff are in compliance with all legal and regulatory requirements applicable to the product lines and markets in which the Company participates
Attention: Human Resources
700 Chesapeake Dr.
Redwood City, CA 94063
Monster - 8 months ago