Executive Director Quality and Regulatory Affairs

This position is incentive eligible.

Introduction: 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

• 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.

Note: Eligibility for benefits may vary by location.

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): Develop policies, provide documentation control oversight, and manage the CAPA (Corrective and Preventive Action) system to correct and/or prevent defects.
• Regulatory Strategy and Compliance: Oversee market access strategies and ensure 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: Partner 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.
• Remain current on all quality/regulatory requirements.
• Drive and maintain Vendor Qualification processes for review/approval of all vendors.
• Maintain the budgets for QRA department, and participate 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.
• Maintain 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%.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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