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Senior Vice President, Clinicals, Quality and Regulatory Affairs

2 months ago

Houston, United States BGSF Full time

Job Duties:


• Clinical studies in all geographies to support regulatory and marketing requirements and align with corporate business strategy development.

• Oversees the company’s quality system and compliance thereto and ensures that the quality system suffices for the products and/or services being provided.

• U.S. and International regulatory product submissions, input on clinical studies to support regulatory and marketing requirements and involvement with corporate business strategy development.

• Design clinical studies that comply with regulatory guidelines, ensure the greatest probability of expedited approval, and meet market needs.

• The position includes oversight of all Clinical, Quality and Regulatory staff and management of external resources.



Job Description:


• Develop the department's strategic and tactical plans.

• Input into design of clinical studies that comply with regulatory guidelines, ensure the greatest probability of expedited approval, and meet market needs, and statistical efficiency and sufficiency.

• Manages and directs the organization regarding all clinical, quality, and regulatory activities by performing the following duties personally or through subordinate managers.

• Responsible budgeting, resource allocation, hiring and training of subordinate personnel

• Develop plans for device approval/clearance submissions.

• Work closely with regulatory agencies to ensure that the company follows all applicable laws.

• Deal with regulatory agencies and processes in major OUS markets

• Oversees the quality function to ensure that quality systems, processes and metrics are in place that meet/exceed worldwide standards.

• Interface with the CEO, executive team, Scientific Advisory Board, Board of Directors, consultants, government agencies, employees, and customers

• Meets with the organization's other executives to ensure that operations are being executed in accordance with the organization's policies.

• Apprise executive team on changing events and laws in the government or industry that could potentially impact the business.

• Review product labeling and promotional documents to minimize exposure to product liability issues while ensuring compliance with regulations.

• Establish and maintain good rapport with key decision-makers within regulatory agencies and medical community.

• Position will oversee multidisciplinary company functions and is an authorized representative for clinical, regulatory, and quality department.

• Provide strategic and tactical regulatory initiatives to support the business objectives and patient quality focus.

• Develop statistical plans that support clinical study protocols for company products.

• Develop or oversee statistical analysis of clinical trials or other company efforts.

• Identify pre-clinical and clinical trial requirements to support regulatory approvals worldwide.

• Experience in compiling IDE, PMA, De Novo and 510(k) submissions.

• Experiencing in submitting device application and obtaining approval for OUS

• Determine regulatory path for second stage product and formulate/execute the plan.

• Collaborate with executive team to develop product launch strategy, marketing/reimbursement plan.

• Interact with the FDA and other governmental agencies on a global basis regarding regulatory and compliance issues.

• Respond to audits conducted at selected study sites.

• Review sales and marketing materials for conformance to regulatory requirements.

• Make the final decision to release or hold commercially approved products based upon conformance to requirements.

• Facilitate in the hiring, training, and retention of other regulatory or quality affairs staff.

• Assists in the identification, assessment, and management/oversight of contracts, CROs, vendors, and program-related consultants.

• Organizes and participates in study team and investigator meetings. • Ensures that regulatory and quality information is effectively communicated throughout the organization. • Represents regulatory department at senior staff level.

• Coordinates all regulatory budgets ensuring that adequate resources are available to accomplish necessary tasks.

• Represents the Company with various State, Federal, and other countries who have responsibility for regulating medical devices.

• Ensures that regulatory information is effectively communicated throughout the organization.

• Work collaboratively with the quality function to ensure that quality systems, processes and metrics are in place that meet/exceed worldwide standards.

• File OUS regulatory and clinical submissions (including CE Marking and international clinical trial applications)

• Review all complaint files for reportability (MDRs and Vigilance) QUALIFICATIONS:



Qualifications:


Degree required (MS or MBA minimum) 10 years related clinical, quality, and regulatory affairs with a preference for M.S. or MBA equivalent.


• Outstanding communication skills (clear and concise in all forms of communications)

• Experience and knowledge of regulatory agencies and process in OUS markets is required.

• Proven history of submissions and approvals with regulatory agencies

• Previous experience in interacting with key decision makers within the FDA.

• Well-rounded mix of experience in both large, well-established medical device companies and early-stage startups

• Solid presentation skills with ability to persuade in a credible fashion.

• Ability to articulate clear visions and expectations for Quality and Regulatory Affairs

• Comprehensive knowledge of FDA regulations and procedures as well as MDSAP, EU MDR, Brazil ANVISA, NMPA, Middle East, Australia, New Zealand, Canada, etc.

• Credible reputation with regulatory agencies through previous submissions of medical devices premarket applications

• Ability to thrive in dynamic small business environments.

• Ability to establish credibility with a broad range of constituents inside and outside the company.

• Creative critical thinking skills and the willingness to take risks and act decisively

• Experience in statistical design and analysis of clinical trials

• Experience in negotiation with regulatory bodies on statistical matters

• Ability to write speeches and articles using original or innovative techniques or style.

• Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or boards of directors.