Senior Director, Quality & Regulatory Notified Body Audits

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $172.8k - $259.2k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

🏥 Healthcare

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 Description

• Represent GE HealthCare to Notified Bodies, certification bodies, auditing organizations, and external regulatory stakeholders • Own the enterprise strategy for Notified Body engagement and certification management • Manage certification transfers, scope expansions, site additions, legal entity changes, remediation strategies, and certification pathway planning • Provide strategic oversight and governance of Notified Body audits, technical documentation assessments, surveillance audits, recertification audits, and unannounced audits • Conduct risk assessment, escalation management, and issue resolution • Develop, standardize, and continuously improve tools and standard work supporting Notified Body engagement • Serve as the primary point of contact between GE HealthCare and Notified Bodies • Drive contract negotiations and resolve certification, compliance, capacity, and service-related concerns • Lead QMS post-acquisition integration assessments for acquisitions, mergers, divestitures, and business expansions • Evaluate compliance, certification impacts, and integration risks and support integration planning • Generate metrics, trend analyses, executive dashboards, and leadership presentations • Lead across regions, business units, product lines, and regulatory frameworks while building stakeholder consensus • Provide executive-level recommendations, develop governance models and reporting metrics, and advise Quality, Regulatory, and business leadership • Drive process excellence, continuous improvement, and organizational readiness

🎯 Requirements

• Master’s degree and a minimum of 10 years’ experience in the medical device industry; or bachelor’s degree and a minimum of 15 years’ experience in the medical device industry • Demonstrated understanding of Medical Device QMS and regulatory requirements including FDA CFR 21 820, EU MDR, MDSAP, and ISO 13485 • Minimum 5 years of progressive Quality and/or Regulatory Affairs experience at a GE HealthCare site • Experience supporting or leading interactions with Notified Bodies during audits, certifications, surveillance activities, technical reviews, or compliance-related engagements • Experience developing metrics, analyzing quality or regulatory data, identifying trends, and preparing executive-level communications or presentations • Expertise communicating on design controls, design verification and validation, production and process controls, CAPA, complaints, risk management, certification strategy, and regulatory compliance expectations • Excellent written and verbal communication skills in English • Commitment to integrity, ethical decision-making, and professional conduct • Understanding of medical device and quality management system certification programs, including EU MDR, MDSAP, ISO 13485, ISO 9001, UKCA, legal entity considerations, and certification management strategies • Experience working directly with Notified Bodies, certification bodies, auditing organizations, regulators, or external regulatory stakeholders in a global medical device environment • Experience managing certification portfolios, Notified Body relationships, contract negotiations, service expectations, and associated budgets • Ability to influence organizational strategy and drive alignment across global functions, business units, sites, executive leaders, and external stakeholders • Strong analytical, problem-solving, and root cause analysis skills • Ability to manage multiple priorities, interpret technical documentation, convert data into actionable insights, and communicate risks clearly • Ability to travel domestically and internationally up to 20% • Must be legally authorized to work in the United States • GE HealthCare will not sponsor individuals for employment visas, now or in the future • Successful completion of a drug screen, as applicable

🏖️ Benefits

• Performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI) • Medical, dental, and vision coverage • Paid time off • 401(k) plan with employee and company contribution opportunities • Life, disability, and accident insurance • Tuition reimbursement • Professional development • Relocation assistance not provided