Vice President Global Quality and Regulatory
Direct message the job poster from MedTech Startup
Co-Founder & Head of Talent of Lifeblood - Executive Search & Business Advisory - MedTech & Digital Health
We are a commercial-stage company developing a multi-product intravascular imaging platform for coronary interventions. Financed by corporate strategic and venture capital investors, we raised our Series B round to scale worldwide commercial efforts. We are hiring our VP of Global Quality Assurance and Regulatory Affairs (QA/RA), based on-site at our headquarters in Bedford, MA.
This position requires direct, in-depth experience leading MedTech Software Quality development and scale-up for electromechanical devices.
We have partnered with the CEO and COO to hire our VP of Global QA/RA. This is an opportunity to build and lead a QA/RA team, report to our COO, and have an executive fingerprint on a worldwide multi-product launch of a software, hardware, and disposable technology system.
This position will own our global QA/RA while leading unannounced audits, managing the FDA, and providing a hands-on contribution overseeing software quality, cybersecurity, and OUS compliance.
Our VP of Global QA/RA will be part of the executive team, driving strategies with our cross-functional teams while ensuring the proper maintenance, evolution, and execution of our QMS, ISO-13485 certification, and FDA, CE Mark, and international regulatory submissions.
This position is based on-site in our headquarters in Bedford, MA. (Relocation assistance available for the right candidate)
Responsibilities
• Develop and execute a comprehensive QA/RA strategy tailored to the unique requirements of the company’s diverse product portfolio, including sterile disposables, complex electromechanical devices, optical systems, and AI/data science applications.
• Build and lead a high-performing QA/RA team, fostering a culture of quality and compliance throughout the organization.
• Serve as the company’s primary point of contact with regulatory authorities, including managing audits, inspections, and submissions for all product categories.
• Stay current with evolving regulatory requirements for medical devices, SaMD, and AI-enabled products, ensuring proactive compliance.
Quality Assurance
• Oversee the development, implementation, and maintenance of a robust Quality Management System (QMS) in compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable standards.
• Ensure compliance with design controls, risk management (ISO 14971), and validation processes during product development, manufacturing, and post-market activities.
• Lead quality assurance activities across the organization, including CAPA (Corrective and Preventive Actions), internal audits, supplier quality management, and non-conformance investigations.
• Collaborate with the Head of Operations to ensure manufacturing processes for sterile disposables, electromechanical components, and optical systems meet quality standards.
Regulatory Affairs
• Develop and execute global regulatory strategies to secure product approval and market access for all product categories, including FDA 510(k), PMA, CE marking, and compliance with MDR and IVDR.
• Prepare, review, and submit regulatory filings, including technical documentation, clinical data, labeling, and SaMD-specific requirements, to appropriate global regulatory agencies.
• Manage interactions with regulatory authorities for all product types, addressing inquiries, resolving deficiencies, and negotiating approval timelines.
• Oversee compliance for AI-driven applications and software as a medical device, ensuring adherence to regulatory frameworks such as the FDA’s SaMD guidance and EU MDR Annex VIII for software.
Cross-Functional Collaboration
• Partner with Product Development to integrate quality and regulatory requirements into the design and development of sterile disposables, electromechanical, optical, and AI-based products.
• Work closely with Operations to align QA/RA activities with production, supply chain, and service processes, ensuring compliance across all stages of the product lifecycle.
• Collaborate with data science teams to address specific regulatory requirements for AI-enabled devices, including validation, training datasets, and bias mitigation.
• Provide guidance and training to cross-functional teams on regulatory and quality best practices to maintain compliance and operational excellence.
• Drive a culture of continuous improvement by identifying opportunities to enhance quality systems and regulatory processes for complex, multi-disciplinary products.
• Implement best practices for streamlining QA/RA activities while maintaining compliance and product quality.
• Monitor key performance indicators (KPIs) related to quality and regulatory compliance and report regularly to executive leadership.
Education & Training
• Bachelor’s degree in Engineering, Life Sciences, or a related field. A Master’s degree or advanced certification in regulatory affairs or quality management is highly desirable.
Skills & Experience
• 10+ years of experience in Quality Assurance and Regulatory Affairs roles within the medical device industry, with at least 5 years in a leadership capacity.
• Strong understanding of FDA regulations, ISO 13485, EU MDR, and other relevant global regulatory frameworks.
• Proven experience managing successful regulatory submissions, including FDA 510(k), PMA, and CE marking.
• Demonstrated ability to lead quality system implementation, maintenance, and compliance for Class II and/or Class III medical devices.
• Experience with post-market activities, including surveillance, adverse event reporting, and field actions.
• Exceptional leadership and team-building skills with a focus on fostering a culture of quality and compliance.
• Deep knowledge of QMS principles, design controls, risk management, and regulatory submission processes.
• Excellent organizational and project management skills, with the ability to handle multiple projects and deadlines effectively.
• Strong communication skills, capable of interacting with regulatory bodies, executive leadership, and cross-functional teams.
• Analytical and problem-solving skills, with a proactive approach to identifying and mitigating compliance risks.
Other Requirements
Ability and willingness to commute or relocate to Bedford, MA
Seniority level
* Seniority level
Executive
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance, Strategy/Planning, and Science
* Industries
Medical Device
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