Vice President, U.S. Regulatory and Quality

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.  

About This Role:

We have an exciting opportunity to join our growing Regulatory, Quality, and Scientific Affairs group at Veranex as a U.S. Vice President, Regulatory and Quality.  The successful candidate will provide leadership and strategic business oversight for the U.S. regulatory and quality department.

What You Will Do:

• Works with EVP to develop and execute department operations initiatives to meet service line and department goals and standards
• Acts as an operational and analytical thought partner to the EVP and leadership team to define, achieve, and measure key service line operational and financial goals
• Drives client corporate initiatives to completion by developing and establishing strategic regulatory and quality plans.
• Interfaces with project team members, both within the organization and with a diverse range of clients.
• Advocates for strategic initiatives & develops approaches (models, frameworks, presentations, recommendations, etc.) for leadership team evaluation and decision-making
• Acts as primary liaison for the management of Regulatory Affairs and Quality with external (i.e., regulatory agencies and customers) and internal stakeholders.
• Provides management and leadership to hybrid regulatory affairs and quality teams, including coordinating program allocations and priorities, training, performance management, professional development, and coaching.
• Organizes regulatory affairs and quality staff to accomplish project goals efficiently.
• Contributes to business development activities as a subject matter expert (SME) by generating strategy, project scoping and proposal documentation.
• Achieves staff results by communicating job expectations; planning monitoring and appraising job results; coaching and counseling employees; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards.
• Leads continuous improvement, change, and compliance.
• Oversees regulatory affairs and quality initiatives designed to address critical business challenges and achieve organizational goals and growth objectives.
• Reports progress, operational issues, and organizational opportunities to the EVP
• Oversees, manages, and participated in the department’s day-to-day project delivery, to ensure quality of output
• Leads the refining of operational processes, systems, and infrastructure increasing performance, and enhancing employee and client experiences
• Reviews, analyzes, and addresses gaps in service excellence, policies, and/or procedures proactively; identify issues and bring forward solutions
• Evaluates performance by analyzing and interpreting data and operation metrics to meet quality/performance metrics
• Manages department growth, employee development, client satisfaction, and general project outcomes within the assigned department
• Proactively engages with cross-functional stakeholders to identify interdependencies, resolve issues, and champion strategic initiatives
• Manages department change initiatives by continuously assessing the department’s needs, championing change initiatives, and overcoming obstacles impeding organizational change
• Prepares the department for both organic growth and potential mergers/acquisitions
• Communicates and explains new operational objectives, policies, or procedures while projecting a positive image of Veranex to employees, customers, industry, etc.
• Leads, motivates, and supports the department within a time-sensitive and demanding environment, including oversight of recruitment, conflict resolution, and client challenges
• Provides leadership to the department, while fostering a culture of accountability, professional development, high-performance, and ethical behavior

Qualifications:

Required skills:

• Bachelor’s degree in life sciences, engineering, or related technical discipline plus a minimum of 15 years of experience in a quality, regulatory role and as a functional manager
• Strong background in medical device industry
• Ability to communicate complex business concepts to a multi-disciplinary audience
• In-depth understanding of applicable regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures
• Advanced knowledge of medical device regulations guidance documents and standards (i.e., quality system regulation (QSR), International Organization for Standardization (ISO) 13485, ISO 14971, ISO 62304, ISO 10993 series, ISO 11135, and ISO 11137 IEC 60601 series IEC 62366, and related ASTM, ANSI, AAMI, TIR standards and guidance documents as needed)
• In-depth understanding of full product life cycle, including definition of customer needs, development, design testing, design transfer, manufacturing scale up, distribution, service, and post market analysis
• In-depth understanding of concepts and principles of regulatory and quality with respect to new product development, requirements of regulatory bodies, external suppliers, product manufacturing and product servicing
• Advanced knowledge of company people management policies and procedures, including hiring, performance management, corrective action, compensation administration
• Strong leadership, collaborative, and interpersonal skills
• Excellent organizational skills
• Excellent communication (written, verbal, and listening) skills and oral presentation ability, as well as the ability to forge successful relationships with internal and external partners
• Outstanding problem-solving skills reflecting creative and analytical thinking
• Strong attention to detail and a downstream understanding of their impact
• Ability to look for and advocate for more efficient and effective methods/processes of operations focusing on key performance metrics around reliability, efficiency, cost, and quality
• Capacity to lead a team through changes and innovation
• Ability to provide innovative approaches that yield practical and scalable solutions

Preferred:

•  Experience in services or consulting preferred.

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy,  gender identity or gender expression), sexual orientation,  parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.