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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. Theyre creating an environment where every team member has a direct impact on their success. Theyre 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 Were 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.
