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Regulatory Specialist | Medical Device | Hybrid | South Wales
Walker Cole International are searching for a Regulatory Specialist to join a growing Medical Device firm in the South Wales region. As a Regulatory Specialist, you will be responsible for the creation and maintenance of technical files, supporting the business's transition from Medical Device Directive (MDD) to Medical Device Regulation (MDR), and liaising with all departments in the business to support the regulatory teams' activities.
As a Regulatory Specialist, you will be required to:
- Support Quality, Regulatory, and Technical teams during external and internal audits
- Support in the dossier preparation process ahead of submission to global regulatory agencies
- Support the engineering team in navigating engineering changes to products in the portfolio
A Successful Regulatory Specialist will demonstrate:
- Regulatory expertise on ISO13485, 21 CFR 820, MDD, and/or MDR
- Knowledge of the regulatory field and function within a business
- Excellent communication both written and oral
This role will operate on a hybrid basis. Candidates will need to be able to access the South Wales region on a weekly basis.
Regulation | Regulatory affairs | Compliance | ISO13485 | MDD | Medical Device Directive | MDR | Medical Device Regulation | Document management | ERP | Medical Device | MD | Registration | Audits | Technical Files | EDMS | Electronic Document Management System |
