Quality & Regulatory Lead

We're seeking an experienced QARA Lead to join an innovative MedTech start-up. This is a unique opportunity to build and oversee our quality assurance and regulatory affairs strategy from the ground up.Our client is a dynamic MedTech start-up focused on innovation and excellence. They’re creating an environment where every team member has a direct impact on their success. They’re at an exciting growth stage where your expertise in QARA will be instrumental in shaping their future.Key Responsibilities :

• Develop and implement comprehensive quality management systems, including risk management strategies, aligned with medical device regulations (ISO13485)
• Lead FDA approval processes and maintain regulatory compliance
• Drive quality assurance initiatives across all product development phases
• Establish and maintain documentation, including technical files, submission dossiers, and risk management files.
• Collaborate with engineering and design teams to combine regulatory and quality requirements into product development.
• Responsible for both internal audits and external inspections.Key Skills & Qualifications :
• Minimum 3 years of experience in QARA within the MedTech industry
• Proven track record in FDA approval processes
• Demonstrated ability to lead projects independently
• Strong problem-solving skills with the ability to find innovative solutions
• Experience working in fast-paced startup environments
• Deep understanding of medical device regulatory frameworks
• Excellent communication and leadership skillsBenefits :
• Share option scheme
• Opportunities to take on the responsibility of QARA strategy from the ground up
• Training and support to help shape your future career
• Flexible working and start-up energyWhat We’re Looking For : The ideal candidate will be adaptable and comfortable in a fast-paced start-up environment. A strategic mindset with the ability to build processes from scratch. Proactive approach to quality and regulatory challenges with strong collaboration skills