Summary: The QA/RA Consultant role focuses on leading Quality Assurance and Regulatory Affairs activities for a medical device project in Greater Manchester. The consultant will ensure compliance with relevant regulations, implement Quality Management Systems, and work on a multi-disciplinary team. This hands-on position offers the opportunity to make a significant impact within a dynamic start-up environment. The contract is initially for six months with a quick interview process.

Key Responsibilities:

• Lead QA/RA activities, ensuring compliance with Medical Device regulations
• Take ownership of QMS implementation and Technical Files
• Focus on FDA 510(k), ISO 13485, and IEC 62304 compliance
• Work on a multi-disciplinary Medical Device project (Electronics, Software, Mechanical, Clinical)
• Contribute to a collaborative and innovative culture within the start-up

Key Skills:

• Experience in Quality Assurance and Regulatory Affairs for medical devices
• Knowledge of FDA 510(k), ISO 13485, and IEC 62304 standards
• Ability to implement Quality Management Systems
• Experience working in multi-disciplinary teams
• Strong communication and collaboration skills

Salary (Rate): £62.50

City: Greater Manchester

Country: United Kingdom

Working Arrangements: hybrid

IR35 Status: outside IR35

Seniority Level: Mid-Level

Industry: Other