QARA Lead (Quality / Regulatory Affairs)

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 in…