Clinical Trials, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
4 Year Degree
Title: Manager/Sr. Manager/Director of Regulatory Affairs
Reports to: CEO
InterVene was founded in 2011, and is a growing start-up medical device company developing a first of its kind minimally invasive therapy for severely symptomatic chronic venous insufficiency (CVI) patients with deep vein reflux. The company is located in South San Francisco and closed a Series B financing in May 2019 with VC and Strategic investment partners. More information can be found at www.intervene-med.com.
Key Responsibilities and Duties
Position works in conjunction with and coordinates/collaborates with both internal company management as well as external regulatory advisors, and works closely with department heads of Clinical Research, R&D / Ops, and Quality Assurance as well as general Executive/Senior Management at Intervene.
1. Responsible for input and collaboration (with company managers, external Regulatory and Clinical advisors/consultants, and scientific/medical advisors) to complete, maintain, and manage the various and ongoing regulatory submissions to the US FDA as well as International governmental agencies/Competent Authority/Notified Bodies, and the like who are associated with the clinical trial/clinical research programs at InterVene. This includes primarily the IDE trial as well as necessary management for the INFINITE-OUS program and any other research initiatives which may be considered. Will primarily execute the tactical aspects of the Regulatory plan based on the strategic direction which the Manager/Director and team devises
2. IDE submissions and reporting including but not limited to IDE submissions for the Feasibility and Pivotal trial phases, Pre-sub and Q-sub proposals, coordination and completion in responding to FDA questions and requests for additional information, real-time reviews, needs for supplements, and required real-time reporting as needed for certain AEs, UADEs, etc. per IDE requirements, as well as APR and other ongoing reporting for the trial.
3. Development, responsibility, ownership and liaison with the FDA reviewer assigned to the InterVene IDE program, and establishment of a favorable rapport with the agency augmenting and expanding that which exists through the current Reg consultants/advisors
4. Provide regulatory input to product development and operational activities such as labeling, regulatory requirements and follow up action to new designs, design changes, and process/supplier/manufacturing changes.
5. Overall Regulatory and QS compliance responsibilities (typical of Reg Affairs) such as co-management and oversight of relevant QS aspects such as Management Responsibility, QS and clinical trial related audits, remedial action determinations and documentation of these, Risk Management, high level CAPA and complaint and device deficiency investigation approvals as well as input and approvals for high level verifications, validations, sterility and related critical process related to FDA submissions. In addition, will provide input to and approve other compliance related assignments which may impact regulatory submissions and/or audits and promotional material and external-facing scientific materials and information
6. Liaison with external economic and reimbursement advisors and in conjunction with the VP of Clinical Research, coordination of trial and regulatory filing activities aligned with future economic and reimbursement needs to support future CMS and private insurer coding/coverage/payment plans and submissions, including input to trial designs, indications, publication plans, and medical society and committee members liaison for this.
7. Individual will handle the filing and supporting documentation for eventual market approval submissions at the completion of the clinical research and will identify future submission deliverables for the regulatory path proposed (likely De Novo 510(k)), associated labeling and indications.
8. Individual will assist in the preparation of status updates and plans including for the CEO to be presented to the Board of Directors, current and potential investors, strategic partners and potential acquirers, and overall assist with special communications and updates as assigned.
Desirable Traits and Characteristics
1. Individual will have very strong written communication skills and will be required to complete extensive submission related documentation, including the ability to craft compelling rationale and provide necessary written justification to support a given company proposal and/or response on a timely basis.
2. Individual will have a strong understanding of US FDA IDE requirements as well as basic medical understanding related to the study, management of adverse events, general cardiovascular and interventional device norms and historical aspects related to procedures, imaging, vascular-related diseases, as well as novel FDA programs available for consideration.
3. Will have strong initiative and resourcefulness and be able to balance and coordinate both internal and external resources to meet filing objectives and timelines, interpret and incorporate external medical advice, and overall act as a central manager and contributor for the various submissions and responses related to the IDE and future US approval submissions.
4. Have a strong understanding of the FDA required regulations including IDE, 510 (k) including De Novo and PMA needs, CFR 820.12 cGMP/QSR requirements, ISO 13485, 14971 Risk Management and MDD 93/42/EEC Directives and other relevant international standards.
5. Manager/Director must have strong teamwork skills and be able/willing to work with varied members, synthesize input from multiple sources, and generally handle integration of all key input of necessary documents, revisions, strategic and tactical input, and meet timeline objectives for submissions and responses by coordinating and directing in-house and outside resources as needed.
Additional Salary Information: Compensation range covers candidates from Manager through Director level, may include equity component in addition to salary
Internal Number: 019-004
About InterVene Inc.
InterVene is a clinical-stage VC and corporate funded medical device start-up located in the San Francisco Bay Area (offices in South San Francisco), and is focused specifically on a non-implant endovenous solution to deep vein reflux, a major contributor to chronic venous insufficiency within the emerging venous intervention field.
The company, with roots in the Stanford University Biodesign program and the Fogarty Institute of Innovation, has a novel catheter-based technology which forms autogenous venous valves within a patient's own femoral or popliteal vein wall, and will be focused on completion of clinical research (including OUS research and a US IDE trial) and the regulatory approval process to gain eventual US FDA market approval.
InterVene recently raised a Series B financing from high quality investors and is expanding the organization with positions necessary to execute the next phase of the business plan, focused on clinical research, necessary operations, engineering, and QA support, and regulatory needs (including QS compliance) to support this and eventual US FDA submissions, audits, etc.
The company has a small but growing staff of passionate, experienced employees as well as a external consultants and physician advisors.