Vice President of Quality Assurance, Regulatory & Clinical

Description

Essential Duties and Responsibilities

Executive Management:

• Serve as a key and active member of the Senior Operational team, interacting with the team to ensure business objectives are aligned and that the company is performing to operational objectives.
• Coach and mentor the Quality, Regulatory and Clinical organization ensuring appropriate levels of accountability for decision making and clearly communicate cross functionally within the organization

Regulatory Affairs:

• Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide.
• Provide counsel, training and interpretation of FDA and other regulatory requirements to all company personnel.
• Oversee preparation and filing of all regulatory documents with the FDA and international regulatory agencies.
• Develop and maintain external relationships with key opinion leaders, medical directors and regulatory officials.
• Direct the development of systems, practices and processes to ensure effective ongoing review of product design and/or manufacturing changes and adverse events.
• Provide leadership and direction for significant deviation events that may impact compliance status or significant business risk.

Clinical Affairs:

• Develop & successfully execute global clinical and regulatory strategies and implementation plans to ensure product approval and adoption while meeting corporate objectives within applicable regulations and guidelines.
• Direct the development of systems, practices and processes to ensure efficient and effective clinical trials including clinical trial management, data analysis, final study report and publication while ensuring all clinical studies operate to the highest ethical and safety standards.
• Keep abreast of competitive regulatory and clinical practices and utilize this knowledge during the ongoing development and adjustment of the company plans.
• Develop and maintain strong internal and external relationships with regulatory bodies and medical/clinical professionals to ensure effective clinical projects are in place and completed to support the company product and technology objectives.

Quality Assurance & Compliance

• Responsible for company's product quality and reliability to meet or exceed customer expectations
• Responsible for company's Quality Compliance to ensure compliance with regulatory agencies and all applicable standards worldwide.
• Develop and execute quality design and quality assurance strategy for new product development and sustaining business activities.
• Effectively create and support process enhancement initiatives to maintain an environment of continuous improvement throughout the organization.
• In support of the quality system, provide effective leadership support, training and guidance to all company personnel.

Qualifications

Education & Experience:

• BA/BS undergraduate degree in life sciences, engineering or business
• M.B.A. or other relevant advanced degree
• 15+ years medical device quality, regulatory and clinical experience in a medical device or life sciences technology driven company.
• Experience in strategic planning and collaboration with executive and key operational groups.
• Progressive & proven record of leadership and managing quality/regulatory/clinical organization's with global responsibility and establishing long term strategic growth initiatives.
• Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization.
• Extensive experience in cGMP and other Regulatory compliance requirements. Experienced in regulatory filings for US (510(k), IDE and PMA) and other key countries/regions.

Required Knowledge, Skills & Abilities:

• High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
• Excellent communications and presentation skills.
• Ability to develop and manage a high performance team focused on accountability and meeting and exceeding expectations.
• Ability to lead, influence, create and work within cross-functional team environments.
• Assertive, take-charge, proven manager with a strong results orientation, positive "can do" attitude and a sense of urgency to get things done.

Success Metrics:

• With the Senior Operating team, ensure continual annual growth with corresponding profit.
• Development and execution of regulatory clinical based strategies which enable the company to achieve set objectives.
• Development and execution of Quality Assurance processes which enable rapid product development and product commercialization.

To find out more about Real please visit www.realstaffing.com