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 start-up 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.