Senior Level Assurance Director Jobs
Senior level assurance director jobs place experienced professionals in charge of audit strategy, risk governance, and the teams responsible for delivering assurance outcomes across the organization. Roles are concentrated in Biotechnology & Pharmaceuticals and Healthcare & Medical Services, with a mix of on-site, remote, and hybrid settings, and employers like Revolution Medicines, Revolution Medicines, and Immunome hiring at this level now.
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Position Summary
Braden Health is seeking an experienced Director of Regulatory Affairs & Quality Assurance to lead regulatory compliance and quality assurance initiatives for our growing medical-device business. This position will oversee regulatory strategy, FDA compliance, and the development and maintenance of quality management systems to support medical-device manufacturing and operations.
The ideal candidate will have demonstrated, hands-on experience in medical-device regulatory affairs and manufacturing quality, including direct authorship and management of FDA 510(k) submissions. This role requires the ability to independently manage regulatory submissions, respond to agency inquiries, conduct regulatory assessments, and establish and maintain quality systems in accordance with applicable FDA regulations and industry standards.
This is primarily a remote position with periodic travel to company locations to support operational oversight, quality assurance activities, audits, and regulatory compliance initiatives.
Essential Duties & Responsibilities
- Develop, implement, and maintain regulatory strategies to support medical-device development, manufacturing, and commercialization.
- Personally author, prepare, and manage FDA 510(k) premarket notifications, including supporting documentation, regulatory assessments, agency responses, and applicable ongoing regulatory filings.
- Monitor changes in FDA regulations, guidance documents, and applicable industry standards to ensure continued compliance.
- Establish, implement, and maintain a Quality Management System (QMS) in accordance with FDA Quality Management System Regulation (QMSR) and ISO 13485 requirements.
- Oversee manufacturing quality assurance activities and ensure compliance with applicable regulatory and quality standards.
- Manage supplier qualification, supplier quality oversight, and ongoing supplier performance evaluations.
- Oversee document control, change management, nonconformance reporting, corrective and preventive actions (CAPA), and other quality system processes.
- Develop and maintain audit programs, including internal audits, supplier audits, and preparation for regulatory inspections.
- Lead responses to regulatory inspections, audit findings, and quality-related investigations.
- Identify compliance risks and implement appropriate corrective actions and process improvements.
- Collaborate with manufacturing, operations, engineering, and executive leadership to support regulatory compliance and quality objectives.
- Conduct periodic visits to company locations to evaluate quality systems, manufacturing compliance, and operational practices.
- Maintain accurate regulatory and quality documentation and ensure records are readily available for audits and inspections.
- Perform other duties as assigned.
Required Qualifications
- Demonstrated experience in medical-device regulatory affairs and quality assurance, preferably within a manufacturing environment.
- Direct, hands-on experience authoring and managing FDA 510(k) submissions from preparation through submission and agency correspondence.
- Practical experience establishing, implementing, or maintaining a medical-device Quality Management System.
- Working knowledge of FDA Quality Management System Regulation (QMSR), ISO 13485, and applicable medical-device regulatory requirements.
- Experience managing manufacturing quality processes, supplier quality programs, corrective actions, document control, and audit activities.
- Strong understanding of FDA regulatory expectations and medical-device manufacturing compliance.
- Excellent written and verbal communication skills, with the ability to prepare technical regulatory documentation and communicate effectively with regulatory agencies.
- Ability to independently manage multiple priorities, assess regulatory risks, and drive projects to completion.
- Ability and willingness to travel periodically to company locations and other business-related destinations.
Preferred Qualifications
- Experience within the pharmaceutical industry or with combination products.
- Experience with FDA inspections and regulatory agency interactions.
- Experience supporting medical-device product development, commercialization, and lifecycle management.
- Experience managing or leading regulatory affairs and quality assurance functions.
Work Environment & Travel
This position is primarily remote, with periodic travel to company locations and other business-related destinations as needed. Travel will support manufacturing oversight, quality assurance activities, supplier audits, regulatory compliance, and operational initiatives. The position requires the ability to work independently while maintaining effective communication and collaboration with leadership and operational teams.
Position Summary
Braden Health is seeking an experienced Director of Regulatory Affairs & Quality Assurance to lead regulatory compliance and quality assurance initiatives for our growing medical-device business. This position will oversee regulatory strategy, FDA compliance, and the development and maintenance of quality management systems to support medical-device manufacturing and operations.
The ideal candidate will have demonstrated, hands-on experience in medical-device regulatory affairs and manufacturing quality, including direct authorship and management of FDA 510(k) submissions. This role requires the ability to independently manage regulatory submissions, respond to agency inquiries, conduct regulatory assessments, and establish and maintain quality systems in accordance with applicable FDA regulations and industry standards.
This is primarily a remote position with periodic travel to company locations to support operational oversight, quality assurance activities, audits, and regulatory compliance initiatives.
Essential Duties & Responsibilities
- Develop, implement, and maintain regulatory strategies to support medical-device development, manufacturing, and commercialization.
- Personally author, prepare, and manage FDA 510(k) premarket notifications, including supporting documentation, regulatory assessments, agency responses, and applicable ongoing regulatory filings.
- Monitor changes in FDA regulations, guidance documents, and applicable industry standards to ensure continued compliance.
- Establish, implement, and maintain a Quality Management System (QMS) in accordance with FDA Quality Management System Regulation (QMSR) and ISO 13485 requirements.
- Oversee manufacturing quality assurance activities and ensure compliance with applicable regulatory and quality standards.
- Manage supplier qualification, supplier quality oversight, and ongoing supplier performance evaluations.
- Oversee document control, change management, nonconformance reporting, corrective and preventive actions (CAPA), and other quality system processes.
- Develop and maintain audit programs, including internal audits, supplier audits, and preparation for regulatory inspections.
- Lead responses to regulatory inspections, audit findings, and quality-related investigations.
- Identify compliance risks and implement appropriate corrective actions and process improvements.
- Collaborate with manufacturing, operations, engineering, and executive leadership to support regulatory compliance and quality objectives.
- Conduct periodic visits to company locations to evaluate quality systems, manufacturing compliance, and operational practices.
- Maintain accurate regulatory and quality documentation and ensure records are readily available for audits and inspections.
- Perform other duties as assigned.
Required Qualifications
- Demonstrated experience in medical-device regulatory affairs and quality assurance, preferably within a manufacturing environment.
- Direct, hands-on experience authoring and managing FDA 510(k) submissions from preparation through submission and agency correspondence.
- Practical experience establishing, implementing, or maintaining a medical-device Quality Management System.
- Working knowledge of FDA Quality Management System Regulation (QMSR), ISO 13485, and applicable medical-device regulatory requirements.
- Experience managing manufacturing quality processes, supplier quality programs, corrective actions, document control, and audit activities.
- Strong understanding of FDA regulatory expectations and medical-device manufacturing compliance.
- Excellent written and verbal communication skills, with the ability to prepare technical regulatory documentation and communicate effectively with regulatory agencies.
- Ability to independently manage multiple priorities, assess regulatory risks, and drive projects to completion.
- Ability and willingness to travel periodically to company locations and other business-related destinations.
Preferred Qualifications
- Experience within the pharmaceutical industry or with combination products.
- Experience with FDA inspections and regulatory agency interactions.
- Experience supporting medical-device product development, commercialization, and lifecycle management.
- Experience managing or leading regulatory affairs and quality assurance functions.
Work Environment & Travel
This position is primarily remote, with periodic travel to company locations and other business-related destinations as needed. Travel will support manufacturing oversight, quality assurance activities, supplier audits, regulatory compliance, and operational initiatives. The position requires the ability to work independently while maintaining effective communication and collaboration with leadership and operational teams.
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Top Industries Hiring
- Biotechnology & Pharmaceuticals
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Senior Level Assurance Director Jobs: Frequently Asked Questions
How do I get a senior level assurance director job?
Employers hiring at this level look for candidates who can own assurance programs end to end, not just execute within them. A strong track of leading audits, managing cross-functional relationships, and influencing risk decisions at the leadership level sets candidates apart. Demonstrating that you have mentored junior staff and driven process improvements tends to carry significant weight in senior searches.
Which companies hire senior level assurance directors?
Companies hiring senior level assurance directors right now include Revolution Medicines, Revolution Medicines, and Immunome, based on current listings on Migrate Mate as of November 2026. Hiring at this level tends to come from large enterprises, professional services firms, and regulated industry organizations that maintain internal audit or risk assurance functions.
Are there remote senior level assurance director jobs?
Yes, though availability varies by employer and industry. About 22% of senior level assurance director openings are remote or hybrid as of November 2026, reflecting ongoing flexibility in corporate audit and risk functions. Fully remote roles are more common at organizations with distributed operations or where assurance work is primarily documentation and review based.
What makes an assurance director role senior level?
Senior level assurance director roles are defined by ownership rather than execution. At this stage, the expectation is that you set the assurance strategy, manage stakeholder relationships at the executive level, lead or oversee a team of audit or compliance professionals, and take accountability for the quality and scope of the entire assurance function, not individual engagements.
Which industries hire the most senior level assurance directors?
Senior level assurance director roles concentrate in Biotechnology & Pharmaceuticals and Healthcare & Medical Services, based on current listings on Migrate Mate as of November 2026. These sectors drive hiring at this level because they operate under significant regulatory oversight, complex risk environments, or reporting obligations that require dedicated senior leadership over internal assurance programs.