Senior RA/QA Manager
2 weeks ago
Walker Cole International is working with a rapidly growing healthcare company that specialises in developing and delivering medical devices and services across a global market. We are seeking a Senior Regulatory and Quality Manager to join their team and to be responsible for the leadership and support of the Regulatory & Quality department.
This full-time position is based in South Wales, UK, and offers a unique opportunity to oversee all activities relating to registration requirements, regulatory strategy and new product development.
Key Responsibilities as the Senior Regulatory and Quality Manager:
- Responsible for the coordination & preparation of regulatory submissions and strategies
- Develop & maintain regulatory knowledge of European, FDA & country specific regulations
- Lead company transition to EU-MDR requirements
- Managing a team
To be successful in your application for the Senior Regulatory and Quality Manager position, you will have the following expertise:
- Proven experience as a Regulatory & Quality professional
- Knowledge of regulatory & quality requirements for medical devices including registration, manufacturing & post marketing controls (including ISO 13485 & ISO 14971)
- Effective people management skills
Regulatory & Quality | Regulatory & Quality Manager | ISO 14001 | ISO 9001 | ISO 13485 | ISO 14155 | South Wales UK | FDA 510(k) | EU-MDR | CER support
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