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VP of Quality amp Regulatory Affairs

Irvine, CA

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nnJob Descriptionn#cb Summary:The role develops and drives the execution of the Company’s regulatory and quality assurance strategies. Overarching responsibilities include the development and implementation of regulatory requirements and directing and improving the quality system. This position serves as a member of the Senior Management Team.Responsibilities:Regulatory AffairsProvides counsel, training, and interpretation of the FDA’s and other regulatory authorities’ feedback, policies, and guidelines.Oversees preparation and filing of all regulatory documents with the FDA and other bodies as required.Provide leadership and direction for deviations that may impact compliance status or raise significant business riskResponsible for keeping the Executive Leadership Team informed of regulatory status and significant regulatory issues.Quality Assurance & ComplianceResponsible for company’s Quality Assurance programs to ensure compliance with regulatory agencies, all applicable standards.Effectively creates and supports process enhancement initiatives to maintain an environment of continuous improvement throughout the organization.Collaborates cross-functionally with internal departments on strategy and implementation of quality principles and regulation requirements.Coaches/mentors staff as a means to ensure performance and professional development.Oversees the management of both the internal and external audit programs by assigning audits to appropriate quality associates and ensures that Quality internal and external audit reports are issued in a timely manner.Prepares clear and concise written reports of audit observations, including an assessment of compliance.QUALIFICATIONS:10 years QA/RA leadership in medical device industry required.Degree in life sciences, engineering, management.Progressive & proven record of leadership and managing quality/regulatory organizations.Experience with all phases of manufacturing and product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization.High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.Ability to lead, influence, create and work within cross-functional teams.Assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude and a sense of urgency to get things done.Well organized, creative, strategic thinker equally capable of tactical execution and driving results.Ability to prioritize projects and deliver quality results within tight time constraints.

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