Are you a seasoned compliance professional with extensive experience in audits and regulatory inspections within the medical device industry? We are seeking a Director of Audits and Inspections (Medical Device) in New York, NY, to lead internal and external audits, ensure regulatory compliance, and oversee global inspection readiness. This executive-level role requires a detail-oriented leader with a strong background in FDA, ISO, and global regulatory standards to drive continuous improvement and ensure adherence to industry regulations.
As the Director of Audits and Inspections (Medical Device) in New York, NY, you will play a crucial role in developing audit strategies, coordinating with regulatory bodies, and implementing best practices for compliance across the organization. If you are an expert in quality systems, risk management, and regulatory compliance in the medical device sector, this is a prime opportunity to make a significant impact while advancing your career in a leadership position.
About This Role
The Director of Audits and Inspections (Medical Device) in New York, NY will be responsible for overseeing all aspects of regulatory audits, compliance assessments, and inspection readiness. This position is vital in ensuring that the company maintains a robust quality management system that aligns with FDA, ISO 13485, MDR, and other global regulations. You will lead audit programs, manage relationships with regulatory agencies, and provide strategic guidance on quality and compliance matters.
In this role, you will work closely with cross-functional teams, including quality assurance, regulatory affairs, manufacturing, and R&D, to address audit findings and drive continuous improvement initiatives. The ideal candidate must have a proactive approach to compliance, a deep understanding of risk-based auditing, and the ability to navigate complex regulatory landscapes. This is an exciting opportunity to lead audit and inspection programs for a top-tier medical device company, ensuring regulatory excellence and product integrity.
Key Responsibilities – Director of Audits and Inspections (Medical Device) in New York, NY
Develop and Oversee Audit Strategy
- Design and implement a comprehensive audit strategy to ensure compliance with FDA, ISO, MDR, and other global regulations.
- Establish an annual audit plan covering internal, supplier, and external regulatory audits.
- Continuously assess the audit process to enhance efficiency and compliance effectiveness.
Lead Internal and External Audits
- Manage and conduct internal audits to assess compliance with quality management systems and regulatory requirements.
- Serve as the primary point of contact during external audits conducted by regulatory agencies.
- Prepare and coordinate audit responses, ensuring timely resolution of findings.
Ensure Regulatory Inspection Readiness
- Develop inspection readiness programs to ensure the company is always prepared for regulatory inspections.
- Train and mentor cross-functional teams on regulatory expectations and best practices.
- Oversee mock inspections and gap assessments to identify and mitigate compliance risks.
Manage Supplier Audits and Quality Compliance
- Oversee supplier qualification and audit programs to ensure compliance with quality and regulatory standards.
- Collaborate with suppliers to address non-conformities and implement corrective actions.
- Establish risk-based supplier monitoring programs to maintain product quality and safety.
Implement Corrective and Preventive Actions (CAPA)
- Lead root cause analysis and CAPA implementation for audit findings and compliance gaps.
- Work with quality and regulatory teams to ensure timely and effective resolution of identified issues.
- Track and report CAPA effectiveness to executive leadership.
Stay Up-to-Date with Regulatory Changes
- Monitor evolving FDA, ISO, and global regulatory requirements to ensure compliance.
- Provide guidance on regulatory updates and their impact on company policies and procedures.
- Participate in industry conferences and regulatory forums to stay ahead of compliance trends.
Train and Develop Audit Teams
- Build and mentor a high-performing audit team with expertise in medical device compliance.
- Develop training programs to enhance audit capabilities and regulatory knowledge.
- Foster a culture of compliance and continuous improvement across the organization.
Collaborate with Cross-Functional Teams
- Work closely with quality assurance, manufacturing, R&D, and regulatory affairs teams to align compliance efforts.
- Support product development teams in meeting regulatory requirements for new and existing products.
- Communicate audit findings and compliance recommendations to executive leadership.
What The Client is Looking For in You
To excel as the Director of Audits and Inspections (Medical Device) in New York, NY, you must bring a strong regulatory background, leadership experience, and a meticulous approach to compliance. The ideal candidate will possess:
- Extensive Experience in Medical Device Audits & Inspections – A proven track record of managing FDA, ISO 13485, MDR, and other global regulatory audits with deep expertise in medical device compliance and quality management.
- Strategic and Hands-On Leadership – Ability to develop and implement audit strategies while also rolling up your sleeves to lead inspections, train teams, and ensure compliance at every level.
- Strong Regulatory Knowledge – A solid understanding of FDA QSR, ISO 13485, EU MDR, MDSAP, and other international compliance frameworks is essential.
- Problem-Solving and Risk Management Skills – Expertise in root cause analysis, CAPA management, and proactive risk assessment to mitigate compliance risks effectively.
- Excellent Communication and Stakeholder Management – Ability to interact with regulatory agencies, executive leadership, suppliers, and cross-functional teams to drive compliance initiatives.
- Detail-Oriented and Proactive Mindset – A keen eye for identifying compliance gaps and implementing best practices to enhance audit readiness and regulatory excellence.
- Proven Ability to Build and Develop High-Performing Teams – Experience in mentoring and developing internal audit teams to ensure a strong culture of quality and regulatory compliance.
Why This Opportunity Stands Out
As the Director of Audits and Inspections (Medical Device) in New York, NY, this role offers:
- A High-Impact Leadership Role – Lead the company’s global audit and compliance strategy, ensuring adherence to the highest regulatory standards.
- Direct Influence on Regulatory Success – Play a pivotal role in shaping how the organization navigates FDA, ISO, and international medical device regulations.
- Opportunity to Work with a Market-Leading Medical Device Company – Join a company at the forefront of medical technology, known for innovation and industry leadership.
- Exposure to Global Markets – Work with international regulatory agencies and compliance teams, making a global impact on quality assurance and audits.
- Competitive Compensation and Executive Perks – Enjoy a lucrative salary, performance-based incentives, comprehensive benefits, and executive-level recognition.
- A Collaborative and Innovative Work Environment – Be part of a culture that values compliance, continuous improvement, and cutting-edge medical advancements.
- Career Growth and Development – A unique opportunity to advance in regulatory leadership, with potential for career progression within a top-tier medical device company.
FAQs About the Role
Q: What industries should I have experience in?
A: You should have extensive experience in the medical device industry, specifically in regulatory audits, quality assurance, and compliance. Experience in FDA-regulated industries is essential.
Q: Is relocation required for this position?
A: This role is based in New York, NY. Candidates must either be local or open to relocation for an on-site leadership position.
Q: What is the reporting structure for this role?
A: The Director of Audits and Inspections (Medical Device) in New York, NY will report directly to the Vice President of Quality and Regulatory Affairs and work closely with the executive leadership team.
Q: What qualifications and certifications are required?
A: A bachelor’s or master’s degree in regulatory affairs, quality management, life sciences, or a related field is required. Certifications such as RAC, CQA, or CQE are preferred.
Q: What kind of leadership style is expected?
A: We are looking for a strategic yet hands-on leader who can drive compliance initiatives, mentor teams, and ensure audit readiness while fostering a collaborative and proactive compliance culture.
Q: What travel requirements are expected for this role?
A: This role may require domestic and international travel to support audits, regulatory inspections, and compliance initiatives. Expect approximately 20-30% travel.
Q: What are the key performance metrics for this role?
A: Success will be measured by audit readiness, regulatory compliance scores, CAPA effectiveness, successful completion of FDA/ISO audits, and team development.
Q: How soon is the company looking to fill this position?
A: The company is actively seeking the right candidate and aims to complete the hiring process within the next 60–90 days.
What Remuneration Can You Expect from This Job?
As the Director of Audits and Inspections (Medical Device) in New York, NY, you can expect a highly competitive compensation package that reflects your leadership role in regulatory compliance and audit management. The base salary for this position typically ranges from $180,000 to $220,000 per year, depending on your experience, industry expertise, and track record in successfully managing audits and inspections within the medical device sector.
In addition to a strong base salary, this position offers performance-based bonuses and incentives tied to key compliance and audit performance metrics, such as successful FDA and ISO 13485 inspections, CAPA resolution effectiveness, and regulatory adherence. Equity options or stock grants may also be available for high-caliber candidates, allowing you to benefit from the company’s long-term success.
The benefits package includes comprehensive healthcare coverage (medical, dental, and vision), a 401(k) retirement plan with company matching, executive-level perks, paid time off, and professional development opportunities. Additional benefits may include a relocation package, travel allowances, and participation in industry conferences.
This role offers not only a lucrative financial package but also an opportunity to lead compliance efforts in a top-tier medical device company while shaping the industry’s regulatory landscape.
How to Apply for This Director of Audits and Inspections (Medical Device) Position in New York, NY
If you are an experienced compliance leader with a strong background in medical device audits, regulatory inspections, and quality management, we encourage you to apply for the Director of Audits and Inspections (Medical Device) in New York, NY. This is an excellent opportunity to work with a leading medical device company, ensuring regulatory excellence and audit readiness.
To apply, please submit your resume and a cover letter detailing your experience in regulatory audits, FDA compliance, ISO 13485 certifications, and quality assurance leadership.
This role offers a rewarding opportunity to join a highly respected organization and play a critical role in shaping audit strategies, managing regulatory interactions, and ensuring global compliance. Apply today to take the next step in your career as the Director of Audits and Inspections (Medical Device) in New York, NY!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
Director of Audits and Inspections | Medical Device Compliance | FDA Audit Leader | ISO 13485 Inspections | Regulatory Affairs Executive | Quality Management
