VP of Quality & Regulatory (Medical Robotics)

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 :

Quality Assurance :