Summary: The role of Medical Device Quality and Regulatory Consultant involves leading Quality Assurance and Regulatory Affairs activities for a developing medical device. The consultant will ensure compliance with relevant regulations, implement Quality Management Systems, and focus on FDA and ISO standards. This hands-on position is within a dynamic start-up environment, emphasizing collaboration and innovation.

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 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): £500

City: Greater Manchester

Country: United Kingdom

Working Arrangements: hybrid

IR35 Status: outside IR35

Seniority Level: Mid-Level

Industry: Other