Executive Director Quality and Regulatory Affairs

HealthTrust is seeking an accomplished Executive Director, Quality & Regulatory Affairs to lead the strategic and operational oversight for all Quality Assurance (QA), Quality Control (QC) and Regulatory Affairs (RA.) This role is responsible for maintaining a comprehensive Quality Management System (QMS), leading hands-on inspection and testing protocols to ensure product reliability and spearheading the design and execution of global regulatory strategies. Acting as the primary liaison for regulatory bodies and auditors, the leader will ensure that all products and manufacturing processes adhere to domestic and international standards, while fostering a cross-functional culture of continuous improvement and risk mitigation. If you are a strategic thinker with strong leadership skills and a passion for driving quality excellence across the product lifecycle, we invite you to join our team!

Benefits HealthTrust Performance Group, offers a total rewards package that supports the health, life, career and retirement of our colleagues. The available plans and programs include: • Comprehensive medical coverage that covers many common services at no cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free telemedicine services and free AirMed medical transportation. • Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness, hospital indemnity), auto and home insurance, identity theft protection, legal counseling, long-term care coverage, moving assistance, pet insurance and more. • Free counseling services and resources for emotional, physical and financial wellbeing • 401(k) Plan with a 100% match on 3% to 9% of pay (based on years of service) • Employee Stock Purchase Plan with 10% off HCA Healthcare stock • Family support through fertility and family building benefits with Progyny and adoption assistance. • Referral services for child, elder and pet care, home and auto repair, event planning and more • Consumer discounts through Abenity and Consumer Discounts • Retirement readiness, rollover assistance services and preferred banking partnerships • Education assistance (tuition, student loan, certification support, dependent scholarships) • Colleague recognition program • Time Away From Work Program (paid time off, paid family leave, long- and short-term disability coverage and leaves of absence) • Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income.

Learn more about Employee Benefits Note: Eligibility for benefits may vary by location. We are seeking a(an) Executive Director Quality and Regulatory Affairs for our team to be an innovator. HCA Healthcare partners with Harvard Pilgrim Institute and the CDC to use our data from more than 26 million patient encounters each year to impact the industry.

Come build your career with us! KEY RESPONSIBILITIES • QMS and QC Oversight: Responsible to maintain an effective QMS (e.g., FDA 21 CFR Part 820, ISO 13485) and manage day-to-day QC activities, including product and service inspections and final product release. • Quality Assurance (QA): Develops policies, provides documentation control oversight, and manages the CAPA (Corrective and Preventive Action) system to correct and/or prevent defects. • Regulatory Strategy and Compliance: Overseeing market access strategies and ensuring compliance with global regulations. • Licensing Management and Distribution Compliance: Direct the acquisition and maintenance of all necessary state and local licenses required for product and/or service sales and distribution. • Audit & Compliance Management: Serves as the primary liaison for regulatory bodies (e.g., FDA, Notified Bodies) and leads through all internal and external audits – received and given. • Risk Management & CAPA: lead risk assessment activities and oversee the Corrective and Preventive Action (CAPA) program to resolve non-conformances and prevent product and process defects. • Post-Market Surveillance: Manage complaint handling, adverse event reporting, and, if necessary, product recalls. • Cross-Functional Collaboration: Partners with legal, sourcing, engineering, manufacturing and supply chain teams to integrate quality and regulatory requirements into products and services offered. • Champion to communicate the quality policy and objectives to all ROi colleagues to ensure quality objectives are met. • Remains current on all quality/regulatory requirements. • Drives and maintains Vendor Qualification processes for review/approval of all vendors. • Maintains the budgets for QRA department, and participates in the forecasting REQUIREMENTS • Bachelor’s or advanced degree in a relevant scientific, pharmaceutical or engineering discipline (e.g., chemistry, engineering) required. MBA is desirable. • Maintains Continuing Education Requirements. • 15 years of proven experience in a highly regulated industry (e.g., medical device, pharma, biotech). • Demonstrated experience with the FDA and Notified Bodies, including prior evidence as lead contact for such regulatory bodies. • Professional certifications such as Regulatory Affairs Certification (RAC), ASQ Certified Quality Manager (CQM).

Six Sigma Green or Black Belts are preferred. • Must be open to travel: variable depending on product and projects, up to 50% In todays challenging business environment of cost pressures, supply disruptions, and workforce shortages, it is crucial for providers to efficiently manage expenses and enhance performance. HealthTrust, in collaboration with 1,800 hospitals and health systems, offers a specialized group purchasing organization (GPO) membership model designed to deliver immediate and sustainable cost savings. Their team of experts provides tailored value acceleration engagements to address specific needs, delivering unparalleled benefits.

With nationwide purchasing power and a focus on overall spending management, HealthTrust offers unmatched pricing advantages on supplies, along with industry-leading benchmarks and best practices. The dedicated team is committed to guiding and implementing performance enhancements in cost, quality, and outcomes.