A Head of Quality & Regulatory Affairs is required for a world class manufacturer in Sheffield. With around 200 heads and a £35M turnover, this is a great opportunity for a candidate to add a world-class business to their resume.
As part of the senior management team, you will provide a service to ensure compliance with the legal requirements for all medical devices regulations along with operating at a strategic level to ensure stringent quality requirements are met.
Head of Quality & Regulatory Affairs duties include:
- Be the main interface with all authorities regarding product manufacture and compliance with MDR
- Ensure that all product conforms to the required standards
- Establish and maintain the CE documentation to ensure that the products manufactured meet with the legislation in force
- Provide strategic advice on packaging and labelling requirements, ensuring compliance with the directives
- Ensure compliance of GMP guidelines in manufacturing situations
- Manage all CE device resignation and licensed medicines manufactured or sold
- Development of the ISO13485 management system
- Develop, manage and inspire the team below
We are interested in speaking to candidates with the following skill set:
- Proven experience in a Quality & Regulatory Affairs role in medical devices at management, director or "head of" level in a medical device manufacturing business
- Extensive European Medical Device Regulation (MDR) experience
- MUST have Class III Medical devices experience
- 13485 management experience
- Degree in either Chemistry or Biology
- Professional, enthusiastic personality
- Proven track record of people development
Are you passionate about driving change in a business where Quality is the key to the business? This is a great opportunity for a Head of Quality & Regulatory Affairs to join a business as it enters an exciting period.
Elevation Engineering & Manufacturing is a specialist recruitment consultancy dealing with senior engineering, technical and operational positions in Yorkshire and the surrounding regions. If you match the specified criteria and are interested in discussing the position in more detail, we would love to hear from you.
Please visit our website for more information on:
- Engineering Jobs or Engineering Recruitment
- Manufacturing Jobs or Manufacturing Recruitment
Iso 13485 Standard
Packaging And Labeling
Good Manufacturing Practices
Medical Device Reporting