Senior Director, Quality & Regulatory Notified Body Audits

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as a representative for GE HealthCare to Notified Bodies, certification organizations, auditing entities, and external regulatory parties.

• Take ownership of the enterprise strategy related to Notified Body engagement and the management of certifications.

• Oversee certification transfers, scope expansions, site additions, legal entity modifications, remediation strategies, and planning for certification pathways.

• Provide strategic governance and oversight for Notified Body audits, technical documentation evaluations, surveillance audits, recertification audits, and unannounced audits.

• Execute risk assessments, manage escalations, and resolve issues effectively.

• Develop and standardize tools and workflows that support Notified Body engagement, continuously improving them.

• Function as the main contact between GE HealthCare and Notified Bodies.

• Lead negotiations for contracts and address concerns regarding certification, compliance, capacity, and services.

• Direct QMS post-acquisition integration evaluations for acquisitions, mergers, divestitures, and business growth.

• Assess compliance, the impact of certifications, integration risks, and assist in planning integrations.

• Create metrics, trend analyses, executive dashboards, and presentations for leadership.

• Collaborate across regions, business units, product lines, and regulatory frameworks to build consensus among stakeholders.

• Offer executive-level recommendations, develop governance models and reporting metrics, and provide counsel to Quality, Regulatory, and business leadership.

• Promote process excellence, continuous improvement, and organizational preparedness.

⛳️ Requirements

• A Master’s degree with at least 10 years of experience in the medical device sector; or a Bachelor’s degree with a minimum of 15 years of experience in the medical device sector.

• Proven knowledge of Medical Device QMS and regulatory standards including FDA CFR 21 820, EU MDR, MDSAP, and ISO 13485.

• At least 5 years of progressive experience in Quality and/or Regulatory Affairs at a GE HealthCare site.

• Experience in supporting or leading interactions with Notified Bodies during audits, certifications, surveillance activities, technical reviews, or compliance engagements.

• Skilled in developing metrics, analyzing quality or regulatory data, identifying trends, and preparing communications or presentations for executive levels.

• Expertise in discussing design controls, design verification and validation, production and process controls, CAPA, complaints, risk management, certification strategies, and regulatory compliance expectations.

• Exceptional written and verbal communication abilities in English.

• A strong commitment to integrity, ethical decision-making, and professional conduct.

• Knowledge of medical device and quality management system certification programs, including EU MDR, MDSAP, ISO 13485, ISO 9001, UKCA, and certification management strategies.

• Experience collaborating directly with Notified Bodies, certification organizations, auditing entities, regulators, or external regulatory stakeholders in a global medical device context.

• Proficient in managing certification portfolios, relationships with Notified Bodies, contract negotiations, service expectations, and related budgets.

• Capacity to influence organizational strategy and foster alignment across global functions, business units, sites, executive leadership, and external stakeholders.

• Strong analytical, problem-solving, and root cause analysis capabilities.

• Ability to juggle multiple priorities, interpret technical documents, transform data into actionable insights, and communicate risks clearly.

• Willingness to travel domestically and internationally up to 20%.

• Must possess legal authorization to work in the United States.

• GE HealthCare will not sponsor individuals for employment visas, either now or in the future.

• Successful completion of a drug screening may be required.

🏝️ Benefits

• Performance-based incentive compensation, which may include cash bonuses and/or long-term incentives (LTI).

• Comprehensive medical, dental, and vision coverage.

• Paid time off.

• 401(k) plan with opportunities for employee and company contributions.

• Life, disability, and accident insurance.

• Tuition reimbursement.

• Opportunities for professional development.

• Relocation assistance is not provided.