Director of Quality Assurance and Regulatory Affa

KEY RESPONSIBILITIES: Ensure all facilities and or business entities maintain full compliance with all applicable state and federal regulatory requirements and guidelines for the marketing, sales, and distribution of the company's products in their respective target markets. Interact with business leads at all relevant facilities to partner to maintain compliance standards and foster market expansion and growth. Ensures facility remains in compliance with all state and federal regulations. Develops and maintains system for monitoring compliance across the business through by implementing and monitoring quality and compliance KPI's and scorecards. Ensure that known compliance risks (via internal/external audits, changes in regulations, changes in business structure/products) are mitigated via quality/compliance plans. Effectively tracks and communicates compliance plans with HS/Business Leadership. Ensures the QA/RA organizations fully understand the requirements of all applicable FDA, ISO, Customs and other Quality/Regulatory requirements for the company. Direct and oversee Quality Assurance internal audit schedules (internal and supplier) and programs to ensure the effective and timely audits. Facilitate and promote cross audits across the businesses. Monitor all CAPA programs to ensure CAPAs are identified and completed in a timely and risk-based manner. Oversee all external audits from Regulatory Authorities and Notified Bodies including responses to any audit findings. Stay current with new or potential business opportunities (M&A, plant movement, business/product expansion, etc.) and ensure adequate plan and resources for all QA/RA activities. Select, develop, and evaluate staff to ensure the efficient operation of the organization. Provide coaching and guidance to direct reports through regular meetings, on-site visits, and communication. Develop and manages departmental expenses and capital budgets. Ensure staff performance review metrics are provided and maintained, and training is provided to meet job qualifications and regulatory compliance. Determine and ensure appropriate regulatory submission strategies to minimize time to market and communicate strategies to management. Participate and communicate on regulatory and compliance issues during regularly scheduled management review meetings and ad hoc as required. Oversee execution of preparation of regulatory submission file, FDA device listings, and establishment registration, CE technical files, state registrations, international product dossiers, for product approvals/registrations with all relevant federal and international agencies. Represent the Quality Assurance and Regulatory Affairs Departments as needed during internal audits, FDA Inspections, and audits by any other agency. Participate in special projects and performs other duties as assigned. SPECIFIC KNOWLEDGE & SKILLS: Strategic planning to ensure QA/RA systems and processes remain current and compliant. Attract, retain, motivate, coach, and develop team members for high performance. Ability to lead and manage complex projects. Excellent decision making skills. Excellent analysis and problem solving skills. Excellent organizational skills and extreme attention to detail. Demonstrated success in negotiations with regulatory bodies and/or notified bodies and other participants. Excellent written and verbal communication skills (including interaction with both internal personnel and external organizations such as regulatory agencies and customers). Ability to read, analyze, and interpret technical journals, legal documents, test reports, clinical and medical terminology, technical product information, and complex documents. Strong PC computer skills with everyday experience working with Microsoft products.