Senior Director, Quality & Regulatory Notified Body Audits

About This Opportunity

Our talent team is representing a confidential medical device organization seeking a Senior Director, Quality & Regulatory Notified Body Audits to lead global certification strategy and regulatory compliance activities. This fully remote position offers the opportunity to serve as the primary strategic interface between our client and Notified Bodies, certification bodies, and regulatory stakeholders worldwide.

In this role, you will drive audit readiness, oversee certification activities, manage regulatory risk, and align regulatory expectations across jurisdictions. You'll establish and continuously improve global processes supporting Notified Body interactions, audits, technical reviews, and regulatory compliance while providing executive-level strategic guidance.

Responsibilities

• Represent the organization to Notified Bodies, certification bodies, and external regulatory stakeholders, establishing strategic relationships that support certification and compliance objectives
• Own enterprise strategy for Notified Body engagement and certification management, including certification transfers, scope expansions, site additions, legal entity changes, and remediation strategies
• Provide strategic oversight and governance of Notified Body audits, technical documentation assessments, surveillance audits, recertification audits, and unannounced audits
• Serve as primary point of contact between the organization and Notified Bodies, driving contract negotiations and resolving certification, compliance, and service-related concerns
• Lead QMS post-acquisition integration assessments for acquisitions, mergers, divestitures, and business expansions
• Generate metrics, trend analyses, executive dashboards, and leadership presentations related to audit performance, certification status, compliance risks, and QMS integration activities
• Manage competing priorities across regions, business units, product lines, and regulatory frameworks while building consensus among stakeholders

What We're Looking For

Required Qualifications:

• Master's degree with minimum 10 years' experience in medical device industry, OR bachelor's degree with minimum 15 years' experience
• 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 with demonstrated responsibility for supporting or leading Notified Body interactions during audits, certifications, surveillance activities, or compliance-related engagements
• Proven experience developing metrics, analyzing regulatory data, identifying trends, and preparing executive-level communications
• Expertise communicating on design controls, design verification and validation, production and process controls, CAPA, complaints, risk management, and certification strategy
• Excellent written and verbal communication skills in English

Desired Qualifications:

• Understanding of medical device certification programs including EU MDR, MDSAP, ISO 13485, ISO 9001, UKCA, and certification management strategies
• Experience working directly with Notified Bodies, certification bodies, and auditing organizations in a global medical device environment
• Ability to influence organizational strategy and drive alignment across global functions and executive leaders
• Strong analytical, problem-solving, and root cause analysis skills
• Ability to travel domestically and internationally up to 20%

Location: Remote (United States)

Visa Sponsorship: Not available for this position

How We Work With You

When you apply through Get A Job.ai, our recruiting team will review your qualifications and conduct an initial screening. We'll discuss your background, experience with Notified Body audits and regulatory compliance, and career objectives. If there's a strong match, we'll submit your profile to our client for consideration. Please apply exclusively through Get A Job.ai—direct contact with the client is not part of this process.

Pay

Pay information will be discussed during the screening process with our recruiting team.

Equal Employment Opportunity: Get A Job.ai is committed to equal employment opportunity. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.