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Head of RAQA

England Permanent View Job Description
The Head of RAQA will be a pivotal figure, steering the Regulatory Affairs and Quality Assurance department within a IVD medical device manufacturer start up. This individual will be responsible for ensuring the company meets industry standards and regulations.
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  • Fantastic opportunity to build the RAQA function for a IVD Start Up
  • Fantastic opportunity to join a start up in an exciting period of growth

About Our Client

Our client is a IVD medical device manufacturer start-up, on a really exciting period of growth and innovation, with an exciting 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.

Contact
Kelly Percival
Quote job ref
JN-012025-6631841
Phone number
+44 1727 730 143

Job summary

Job function
Life Sciences
Subsector
Regulatory Affairs
Sector
Healthcare / Pharmaceutical
Location
England
Contract type
Permanent
Consultant name
Kelly Percival
Consultant phone
+44 1727 730 143
Job reference
JN-012025-6631841