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Position: Sr. Technology Quality Consultant - Medical Devices  (Full Time Contract-to-Hire) 

Reports to: Chief Product and Compliance Officer (CPO)  

Location: Remote (Headquarters in Boston and San Francisco) 

At GxSpeed, our mission is to bring innovative solutions and life-saving therapies to people faster. By blending strategic execution, technological innovation and operational excellence, we optimize our clients’ operations to drive down unit economics and accelerate growth.  As a forward-thinking company, we are committed to driving change and making a significant impact on the life sciences ecosystem. 

As we continue to expand, we’re looking for passionate and driven professionals to join our team. This is an exciting opportunity to work in a fast-paced, entrepreneurial environment and directly contribute to the growth and success of the firm. 

Position Overview:  

We are seeking a highly experienced and knowledgeable Sr. Technology Quality Consultant with a deep understanding of medical device regulations and technology to join our growing consulting practice. This role will provide expert guidance to medical device companies on quality management systems (QMS), regulatory compliance, and technology implementation, with a specific focus on Software as a Medical Device (SaMD) and devices with integrated technology. The ideal candidate possesses a strong background in quality assurance, regulatory affairs, and software development within the medical device industry, with a minimum of 7 years of experience. 

Key Responsibilities: 

• Provide expert consulting services to medical device clients on a range of quality and regulatory topics, including:  
• QMS implementation and maintenance (21 CFR Part 820, ISO 13485) 
• Software validation (21 CFR Part 11, GAMP 5) 
• SaMD development and compliance (IEC 62304, IMDRF SaMD Guidance) 
• Cybersecurity for medical devices 
• Data integrity and data governance 
• Risk management (ISO 14971) 
• Usability engineering (IEC 62366) 
• Clinical evaluation and post-market surveillance 
• Technical file/design history file (DHF) preparation 
• Lead and participate in client engagements, including assessments, gap analyses, remediation projects, and audits. 
• Develop and deliver training programs on quality and regulatory topics. 
• Author and review technical documentation, including SOPs, work instructions, and reports. 
• Stay up-to-date on current and emerging medical device regulations, standards, and guidance documents. 
• Contribute to the development of thought leadership content (e.g., white papers, webinars, presentations). 
• Collaborate with other consultants and subject matter experts to deliver comprehensive solutions to clients. 
• Build and maintain strong client relationships. 
• Support business development activities, including proposal writing and presentations. 
• Provide guidance on the application of technology in medical devices, including embedded software, mobile apps, and cloud-based solutions. 
• Advise on the integration of AI/ML in medical devices and associated regulatory considerations. 

Qualifications & Skills: 

• Bachelor's or Master's degree in a scientific, engineering, or related field (e.g., Biomedical Engineering, Computer Science, Regulatory Affairs). 
• Minimum of 7 years of experience in quality assurance, regulatory affairs, or software development within the medical device industry. 
• Deep understanding of medical device regulations (21 CFR Part 820, ISO 13485, EU MDR/IVDR). 
• Specific expertise in SaMD development, validation, and compliance (IEC 62304, IMDRF SaMD Guidance). 
• Strong knowledge of software development lifecycle (SDLC) methodologies. 
• Experience with risk management processes (ISO 14971). 
• Excellent written and verbal communication skills. 
• Strong analytical and problem-solving skills. 
• Ability to work independently and as part of a team.    
• Ability to manage multiple projects simultaneously. 

Preferred Qualifications:  

• RAC (Regulatory Affairs Certification) or other relevant certifications. 
• Experience with cybersecurity standards for medical devices (e.g., NIST Cybersecurity Framework). 
• Experience with cloud computing and its application in medical devices. 
• Experience with AI/ML in medical devices and associated regulatory considerations. 
• Experience with Agile software development methodologies. 

Travel: 

• May require travel to client sites (percentage will vary depending on project needs). 

What We Offer: 

• An innovative and quickly-growing company with significant opportunities for professional growth. 
• Access to cutting-edge tools, technologies, and resources to support your professional development. 
• The opportunity to work on impactful products and services that improve healthcare outcomes and accelerate Life Sciences innovations. 
• Competitive salary based on experience, with performance-based incentives and the opportunity to transition into a permanent, full-time role after the contract period. 
• Enjoy the benefits of a flexible work environment, with remote work options and the ability to manage your work schedule. 

At GxSpeed, you will have the opportunity to work with a diverse and talented team of professionals on cutting-edge projects in the Life Sciences space. You will be part of a company that values innovation, continuous learning, and growth. We offer a dynamic and supportive environment where your contributions will have a direct impact on our success and the success of our clients.  

If you’re a strategic, results-driven consultant who thrives in a collaborative, fast-paced environment, we’d love to hear from you! 

Email your resume to kelly.protasewich@gxspeed.com if you are a good fit for this role.

GxSpeed is an equal opportunity employer and is committed to creating a diverse environment. We encourage individuals of all backgrounds to apply.