Contract Quality/Regulatory Specialist (Outside IR35)

We are currently recruiting for an exciting new contract opportunity to assume a role in a highly successful and expanding Medical Device company. We are looking for an accomplished medical device quality and regulatory professional to help get the latest products to market.

The Opportunity Includes

• Work within a well-established Medical Device development company.
• Produce all necessary technical documents including, but not limited to, Requirements Specification, Design Specification, Input Output Verification Matrix, Verification and Validation, Performance Evaluation Report and Risk assessment.
• Review existing design and development documentation and carry out gap analysis against the GSPR of the IVDR regulation.
• Compile Summary Technical Documentation
• Lead the development of Design History File

What is needed for me to be considered?

• Applicants should have at least 5 years' in the Medical Device sector.
• Experience of delivering technical documentation for CE marking for active devices.
• Knowledge of EU/US Medical Device regulatory procedures and requirements.
• Working knowledge of risk management - ISO 14971:2019 and advanced knowledge of ISO 13485:2016 standards.

What next?

Apply today to be considered for this opportunity. If this specific vacancy is not exactly what you are looking for please contact us to discuss other opportunities we may be recruiting for that aren't necessarily advertised; you can send your CV to this vacancy or contact us directly. Additionally, refer a friend or colleague to us and receive GBP200 in vouchers if we assist them in securing a new career.