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VP of Regulatory Affairs Quality Assurance

Company: Medical Devices / Equipment, Orange, CA
Location: Orange
Posted on: December 9, 2018

Job Description:


The VP, Regulatory Affairs and Quality Assurance for KaVo Kerr will lead all aspects of Regulatory Assurance, Design Assurance, Quality Assurance/Control, and Regulatory Compliance for the global organization. S/He will be a member of the Operating Company Senior Leadership Team responsible for driving the overall business strategy and execution and will work closely with other members of the Leadership Team to help achieve our business growth, profitability, and quality objectives. The VP, Regulatory Affairs and Quality will have overall responsibility for developing an effective and diverse global organization capable of supporting our global Business Units, Manufacturing, and Commercial teams. The KaVo Kerr RA/QA team consists of 8-10 direct reports and ≈230 associates globally with a majority of the team (80%) located at our Product Development and Manufacturing locations in North America and Europe. The KaVo Kerr global footprint supported by the RA/QA organization includes the following site locations:

North America (6): Orange, CA; Pomona, CA; Romulus, MI, Morrisburg, CAD; Hatfield, PA; Charlotte, NC Europe (5): Biberach, Germany; Tuusula, Finland; Bioggio, Switzerland; Scafati, Italy; Jicin, Czech Republic Latin America (3): Joinville, Brazil; Merida, Mexico; Mexicali, Mexico

Key focus areas are: Continuous Improvement & Simplification of Processes and Systems; Support of New Product Development Programs; Global Registration of Products; Manufacturing Quality Improvements; Regulatory and Quality Compliance; Building, Developing, and Engaging a Diverse Global Organization.

Key Responsibilities (Quality Assurance & Compliance): Responsible for leading company’s product quality and reliability process, systems, and culture to meet and exceed customer expectations. Responsible for company’s Quality Compliance to ensure compliance with relevant external and internal regulatory requirements and all applicable standards. Responsible for setting and achieving quality goals and metrics associated with Company Core Value Drivers (CVDs) and Key Performance Indicators. Provide executive leadership of Company Business System (DBS) culture around quality, reliability, and other lean, leadership, and growth tools. Develop and execute design assurance strategy in support of new product development and sustaining business activities while ensuring compliance to regulatory compliance. Effectively create and support process improvement, harmonization, and simplification efforts to lead and advance continuous improvement culture throughout the organization. In support of the quality system, provide effective leadership support, training, and mentorship to KaVo Kerr RA/QA organization and other functional teams (R&D, Manufacturing, Commercial, etc.) Build strong relationships with internal and external customers to build, enhance, and ensure quality awareness. Develop the required site processes and competencies to ensure that quality standards are implemented in accordance with corporate goals. Ensures the proper interface of the quality function to product development, manufacturing, engineering/maintenance, and other areas as required. Key Responsibilities (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. Provide leadership, training and interpretation of FDA and other regulatory requirements to all company associates within RA/QA organization and other functional teams. Oversee preparation and filing of all regulatory documents with the FDA, EPA, Health Canada, ISO and other regulatory agencies. Develop and maintain external relationships with key opinion leaders and regulatory officials. Direct the development of systems, practices and processes to ensure effective ongoing review of product design and/or manufacturing changes and post-market surveillance. Provide leadership and direction for significant regulatory changes that may impact compliance status or represent significant business risk. Qualifications

Key Abilities: Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product development/clinical manufacturing and commercial operations Has an excellent understanding of Quality requirements globally, specifically US and EU. Proven expertise in the design and implementation of quality processes in a world-class medical device manufacturing organization Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance Must have technical competence and knowledge of device product design, manufacturing, process design and improvement and act as an open and accessible resource to peers Must have a track record of success and a broad understanding of contemporary quality practices for medical device and combination product platforms Extensive relevant experience applying Quality risk management for device product development and manufacturing Knowledge of current FDA, EPA, ISO and Health Canada guidelines. Proven history of building strong collaborative relationships with regulatory agencies. Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization. Extensive experience in GMP and other Regulatory compliance requirements. Experienced in regulatory filings for US (510(k), EU and other key countries/regions. Experience and facility working in a lean/kaizen culture, with a track record of utilizing these methodologies as a competitive advantage. Key Personal Attributes: Leader – Willing to take risks, possess self-confidence and the ability to work with all levels of organization Balance – A calm presence in tense situations and an ability to address competing priorities Influence – Able to influence direct reports, leadership staff, internal and external stakeholders Strategic – Able to make decisions quickly that drive Company goals and objectives Communication – Able to effectively communicate in both written and verbal forms Courageous – Capable of asking the right questions and making the tough decisions; not overly sensitive Logical – Adept at to think on one’s feet Ethical – Operates in a way that never compromises ethics and integrity Teamwork – A leader and empowerer of teams of Company employees from multiple disciplines and/or companies Talent Development – A track record of selecting and developing talent Global Thinking – A disposition to understand different cultures and market needs Because there is significant complexity in this business, driven by diversity of products, customers, and channels, a matrix organization, breadth of technologies and stretch goal culture of the business, it will be imperative that the successful candidate possess a strong intellect, agility, sound judgement and the ability to think creatively. Travel Requirements: Domestic and international travel is required for this role 40%-50%

Keywords: Medical Devices / Equipment, Orange, CA, Orange , VP of Regulatory Affairs Quality Assurance, Executive , Orange, California

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