Senior Director, Quality & Regulatory Notified Body Audits

Job description

Job Description Summary The Senior Director, Q&R Notified Body Audits provides global leadership for Notified Body engagement, certification strategy, audit governance, and regulatory compliance activities across GE HealthCare. Serving as the primary interface between GE HealthCare, Notified Bodies, certification bodies, and manufacturing and development sites worldwide, this role drives audit readiness, oversees certification activities, manages regulatory risk, and aligns regulatory expectations across jurisdictions. The position establishes and continuously improves global processes supporting Notified Body interactions, audits, technical reviews, certifications, and regulatory compliance. The Senior Director also leads QMS integration assessments associated with acquisitions, mergers, divestitures, and business expansions, including evaluation of quality system maturity, compliance, certification impacts, and integration risks. The role provides executive-level recommendations, develops governance models and reporting metrics, and serves as a strategic advisor to Quality, Regulatory, and business leadership. As a recognized subject matter expert, the Senior Director drives process excellence, continuous improvement, and organizational readiness to support sustained compliance and business objectives. Job Description Roles and Responsibilities Represents GE HealthCare to Notified Bodies, certification bodies, auditing organizations, and external regulatory stakeholders, establishing strategic relationships that support certification activities, regulatory compliance, and business objectives. Owns the enterprise strategy for Notified Body engagement and certification management, including certification transfers, scope expansions, site additions, legal entity changes, remediation strategies, and certification pathway planning. Provides strategic oversight and governance of Notified Body audits, technical documentation assessments, surveillance audits, recertification audits, and unannounced audits, including risk assessment, escalation management, and issue resolution. Develops, standardizes, and continuously improves tools and standard work supporting Notified Body engagement. Serves as the primary point of contact between GE HealthCare and Notified Bodies, driving contract negotiations and resolving certification, compliance, capacity, and service-related concerns. Leads QMS post-acquisition integration assessments for acquisitions, mergers, divestitures, and business expansions, including compliance evaluations, certification impact assessments, and supporting integration planning. Generates metrics, trend analyses, executive dashboards, and leadership presentations related to audit performance, certification status, compliance risks, Notified Body effectiveness, and QMS integration activities. Leads through complexity by managing competing priorities across regions, business units, product lines, and regulatory frameworks while building consensus among internal and external stakeholders. Required Qualifications 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 but not limited to 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, with demonstrated responsibility for supporting or leading interactions with Notified Bodies during audits, certifications, surveillance activities, technical reviews, or compliance-related engagements. Demonstrated experience developing metrics, analyzing quality or regulatory data, identifying trends, and preparing executive-level communications or presentations to support decision-making. Demonstrated expertise communicating across all levels of the organization 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, with a demonstrated commitment to integrity, ethical decision-making, and professional conduct. Desired Characteristics Demonstrated 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 including managing certification portfolios, Notified Body relationships, contract negotiations, service expectations, and associated budgets. Demonstrated 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, with the 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%. We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $172,800.00-$259,200.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No Application Deadline: September 25, 2026