Job Description

VP of Quality & Regulatory (Medical Robotics)

The Company:

Our client is a well funded startup company in the medical robotics space. They currently have a successful commercial product with several new exciting products in their pipeline. This exciting opportunity will help grow and shape the quality organization for years to come.

Target Experience:

• Extensive experience in regulatory affairs and quality management within the medical device, biotechnology, or related industries.
• Proven track record of successful regulatory submissions, quality audits, and continuous improvement initiatives including clearance of multiple complex medical devices, i.e. devices that include capital hardware, disposable hardware, and software.
• In-depth knowledge of regulatory requirements, standards, and guidelines (e.g., FDA, CFDA, EU MDR, EMA, ISO).
• Strong understanding of quality management systems, including GMP, GCP, and ISO standards, e.g. 13485.
• Excellent leadership, communication, and interpersonal skills.
• Strategic mindset with the ability to drive change and foster innovation.
• Thrives in a fast-paced, hands-on environment that is frequently changing.
• Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences
• Exceptional problem-solving and decision-making abilities.
• Demonstrated experience in building, leading, and developing high-functional teams, with demonstrated success in fostering collaboration, innovation, and professional growth.

Job Responsibilities:

• Advocate for the company's regulatory and quality interests and represent the organization in regulatory discussions, audits, inspections, and quality management reviews.Regulatory Compliance:
• Stay abreast of relevant regulatory requirements, guidelines, and industry best practices.
• Develop and implement strategies to ensure compliance with local, national, and international regulations.
• Ensure regulatory compliance by overseeing advertisement and promotional programs, including review and approval of marketing materials, advertising campaigns, and promotional activities in alignment with FDA regulations and international standards.
• Quality Management Systems:
• Establish and maintain robust quality management systems (QMS) to support the organization's operations.
• Lead the development, implementation, and maintenance of quality policies, procedures, and processes.
• Monitor and evaluate the effectiveness of the QMS through audits, inspections, and metrics analysis.

Quality Assurance:

• Lead Design Control program to ensure that design inputs, verification, validation, and design transfer activities meet regulatory requirements and quality standards.
• Develop and implement post-market surveillance strategies, including complaint handling, adverse event reporting, and corrective and preventive action (CAPA) processes, to ensure ongoing product safety and regulatory compliance.
• Collaborate with cross-functional teams to address quality issues and drive corrective and preventive actions.
• Risk Management:
• Identify and assess regulatory and quality risks associated with products, processes, and systems.
• Develop and implement risk management strategies for hardware and software components, including risk assessment, mitigation plans, and risk-based decision-making processes to minimize compliance and quality-related risks.
• Provide guidance on risk management principles and practices to relevant stakeholders.
• Leadership and Team Management:
• Recruit, develop, and retain a high-performing team of regulatory and quality professionals.
• Foster a culture of accountability, collaboration, and continuous improvement within the department.
• Provide leadership, guidance, and mentorship to team members to support their professional growth and development.
• Provide strategic regulatory/quality guidance to the leadership team in support of decision-making.
• Provide strategic leadership in regulatory affairs and quality assurance, develop regulatory and quality strategies aligned with business objectives, and oversee the execution of regulatory and quality plans throughout the product lifecycle.
• Cross-Functional Collaboration:
• Collaborate with other functional areas, including R&D, manufacturing, supply chain, and commercial teams, to integrate regulatory and quality considerations into product development and commercialization strategies.
• Serve as a subject matter expert on regulatory and quality matters, providing guidance and support to cross-functional teams.
• Continuous Improvement:
• Drive continuous improvement initiatives to enhance regulatory compliance and quality performance.
• Champion quality excellence and promote a culture of quality throughout the organization.
• Implement quality improvement tools and methodologies to streamline processes and optimize resource utilization.

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