Regulatory Affairs Manager
7 days ago
Dentsply Sirona is looking for a highly skilled Regulatory Affairs Manager to join our team. As a key member of our QA/RA department, you will be responsible for maintaining and developing the local quality and pharmacovigilance management system.
The ideal candidate will have a strong background in regulatory affairs and quality management, with significant experience working in highly regulated environments such as ISO 13485 and GDMP. Project management experience is desirable but not essential.
Salary: £65,000 - £85,000 per annum (dependent on experience)
This role will involve supporting the product registration process with local competent authorities and managing various projects. You will also be required to maintain an effective ISO 13485 certified Quality Management System (QMS) and ensure regulatory compliance of the site according to UK and Ireland regulations for Pharma and Medical Device distribution.
About Us:
- We are a leading international company in the dental industry.
- We offer a comprehensive induction program, further training opportunities and access to LinkedIn Learning.
- We have a worldwide mentoring and coaching program to help you achieve your goals.
Key Responsibilities:
- Develop and implement a quality management system that meets the requirements of ISO 13485.
- Support the preparation and coordination of data and analytics for the monthly Product Surveillance Committee.
- Maintain good documentation practice and manage the UKD Document Control infrastructure.
Benefits:
- 26 days' annual leave.
- An attractive company pension scheme.
- A flexible benefit scheme including health insurance and dental cover.
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