Summary: The role of Contract Quality Assurance (QA) / Regulatory Affairs (RA) Consultant focuses on leading QA and RA 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 position offers an opportunity to make a significant impact in a dynamic start-up environment. The contract is for an initial duration of six months with a hybrid working arrangement.

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)
• Join a dynamic start-up where you can make a real impact on Quality Assurance & Regulatory Affairs

Key Skills:

• Experience in Quality Assurance and Regulatory Affairs within the medical device industry
• Knowledge of FDA 510(k), ISO 13485, and IEC 62304 standards
• Strong understanding of Quality Management Systems (QMS)
• Ability to work collaboratively in a multi-disciplinary team
• Hands-on approach to problem-solving and project management

Salary (Rate): £500

City: Greater Manchester

Country: United Kingdom

Working Arrangements: hybrid

IR35 Status: outside IR35

Seniority Level: Mid-Level

Industry: Other