Head of RAQA

Michael Page (UK); England; On-site; GBP 50,000 - 90,000; Full time

Job description

• Fantastic opportunity to build the RAQA function for an IVD Start-Up.
• Fantastic opportunity to join a start-up in an exciting period of growth.

About Our Client

Our client is an IVD medical device manufacturer start-up, in a really exciting period of growth and innovation, with a pipeline of products under development.

Job Description

• Implement and manage the QMS.
• Creation of SOPs.
• Ensure compliance with industry standards and regulations.
• Implement and manage RAQA processes and systems.
• Hands-on with the creation of technical files and coordinate with other departments to ensure regulatory compliance.
• Assist in product development to ensure regulatory standards are met.
• Oversee audits and inspections.
• Address and resolve regulatory and quality issues.

The Successful Applicant

A successful 'Head of RAQA' should have:

• Appropriate educational qualifications in Life Sciences or a related field.
• Strong experience in IVD Regulations.
• Experience in implementing QMS & SOPs.
• Strong understanding of industry standards and regulations.
• Proven track record in managing RAQA processes and systems.
• Effective leadership and team management skills.
• Experience in coordinating with other departments for regulatory compliance.
• Experience in managing audits and inspections.
• Ability to address and resolve regulatory and quality issues.
• Experience in Endotoxin would be advantageous.

What's on Offer

• Competitive salary and benefits package.
• Opportunity to lead and shape the RAQA department.
• Work within a company that values innovation and quality.

We encourage experienced and interested candidates to apply for this opportunity to lead and make a difference in an innovative start-up company within the medical devices sector.