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Senior Vice President

2 months ago

Houston, United States BGSF Full time

Job Description

The Senior Vice President of Clinical, Quality and Regulatory Affairs is responsible for providing the strategic direction and tactical management of all Clinical, Quality and Regulatory Affairs functions. These strategies include the development and implementation of:

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.


This Senior Vice President of Clinical, Quality and Regulatory Affairs is a key member of the executive team. This position directly reports to the President & CEO. Senior Vice President Clinical Affairs pays attention to clinical problem solving, health economics, broad customer needs, sound operating principles including budget prudence, excellent talent management and nurturing and efficient manufacturability as well as advancing the highest standards of Quality and compliance. The person holding this position pays attention to trends in clinical affairs, regulatory affairs, new regulations or standards, and new approaches to maintaining a quality system. The person incorporates sound operating principles including budget prudence, excellent talent management and nurturing and efficient manufacturability as well as advancing the highest standards of quality and compliance. The person develops and implements methods and procedures for designing, monitoring, analysis, and reporting trials/projects such as preparation of records of expenditures and research findings, progress reports, and staff conferences, to inform executive team of current status of each trial/project.



Essential Duties

  • Design clinical studies that comply with regulatory guidelines, ensure the greatest probability of expedited approval, and meet market needs.
  • Manages and directs the organization regarding all clinical, quality, and regulatory activities by performing the following duties personally or through subordinate managers.
  • Responsible for all activities related to the Quality and Regulatory department, including budgeting, resource allocation, hiring and training of subordinate personnel.
  • Actively participates with executive team to achieve the Company’s overall business objectives. 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.
  • Develop plans that will clearly define the most exact, expedient method of approval for device approval/clearance submissions.
  • 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
  • Collaborate to define business strategy and have a strong voice in overall direction as a member of executive team.
  • 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.
  • Work closely with all functions of the company to ensure that strategies to maximize revenue and profit objectives are safeguarded through controls to minimize potential regulatory exposure
  • Establish and maintain a good rapport with key decision-makers within regulatory agencies and the medical community. Maintain both domestic and international regulatory compliance for all products manufactured by our Technology
  • 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. Assists CEO in short/long-term project planning.
  • 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.
  • Work with executive team to develop product launch strategy, marketing/reimbursement plan. Job Description
  • Review and approve company documents from a regulatory perspective.
  • Oversee interactions with suppliers to ensure compliance to company’s quality system.
  • Input into technical scientific publications strategy.
  • 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.
  • Participate in the Company’s strategic development and implementation of Quality Systems.
  • Attends Product Team meetings and design review meetings to ensure adequate clinical, quality and regulatory direction is provided. Responsible for providing strategic direction to the Company on all regulatory related matters. Directs the regulatory department in the handling of U.S. and OUS clinical studies ensuring that all State, Federal, and other regulatory agency requirements, and internal company policies and procedures are being followed.
  • Ensures that regulatory information is properly communicated throughout the organization.


Qualifications

  • 15 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 track record 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.
  • Access to a diverse network of individuals to consult when critical decisions require third-party perspectives. Ability to build and lead teams.
  • Intellectual depth and strength of character
  • Ability to establish credibility with a broad range of constituents inside and outside the company.
  • Creative problem-solving skills and the willingness to take risks and act decisively (but should communicate potential consequences to enable informed business decisions) Job Description
  • Ability and willingness to "roll up the sleeves" and become actively engaged in tactical execution.
  • Ability to extract and position key data elements from clinical studies that support safety and effectiveness in a concise, compelling manner.
  • Experience in statistical design and analysis of clinical trials
  • Experience in negotiation with regulatory bodies on statistical matters