Quality & Regulatory Lead Job

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Quality & Regulatory Lead

Job Posted: 18 days ago

  • Salary: £ 80,000/Annum

    Job Type: Permanent

  • Location: W14, Avonmore and Brook Green, Greater London

Expire in: 10 days

Job Description

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 skills Benefits: * 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 energy What 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

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