Position Overview
SpectraWave is a commercial-stage company developing an intravascular, AI, imaging platform for percutaneous coronary interventions. Backed by marquee investors in MedTech such as Deerfield Management, Johnson & Johnson, SV Health, and Heartwork Capital (Owned by former CEO of Abiomed that led a $17B exit to J&J), SpectraWave has raised $50M to scale commercial efforts, which necessitates augmented manufacturing capabilities. We are hiring our Head of Quality Assurance and Regulatory Affairs.
We have partnered with Eman Namati, CEO, and Vivek Walimbe, COO, to hire our Head of Quality Assurance and Regulatory Affairs. This position will own Quality and Regulatory activities during our commercial scale-up with a direct oversight of SW Quality and Cybersecurity. Our Head of Quality and Regulatory will manage and maintain and evolve our QMS, ensure ISO-13485 requirements, and guide regulatory on FDA and international submissions.
This position is based on site at SpectraWave’s headquarters in Bedford, MA. (relocation assistance available for the right candidate)
Position Details
Responsibilities
Leadership & Strategy
• 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.
Continuous Improvement
• 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
Company Overview
SpectraWAVE is a dynamic, venture-backed medical device startup on a mission to revolutionize the treatment of coronary artery disease (CAD)—the leading cause of mortality worldwide. Our flagship product, the HyperVue™ Imaging System, is FDA-cleared and represents a next-generation approach to intravascular imaging. By combining advanced DeepOCT™ technology, near-infrared spectroscopy (NIRS), and cutting-edge machine learning algorithms, HyperVue™ optimizes coronary stenting procedures, empowering interventionalists with precise, real-time insights in the catheterization lab.
Recently, SpectraWAVE secured a $50M Series B funding round led by Johnson & Johnson Innovation - JJDC, Inc., alongside other prominent MedTech investors. This capital infusion is accelerating our commercial expansion and driving product enhancements that will set new standards in cardiovascular care.
As we expand our presence in the U.S. market, we're seeking passionate, driven professionals to join our small, innovative team. At SpectraWAVE, we strive to make a direct impact on patients' lives by advancing technology that improves outcomes. If you're excited to be part of a collaborative and fast-paced environment where your work can truly make a difference, we want to hear from you.
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