Do you want to want to work within the healthcare industry? Do you have a degree in a scientific discipline?
Our client is searching for a Quality and Regulatory Assistant to join their team.
About the Company:
Our client is a leading consulting firm in the healthcare industry who specialise in orthopedic medical devices. With over 50 years of combined experience in the industry, the company provides comprehensive consulting services to clients worldwide. The team of experts includes seasoned executives, surgeons, engineers, and market analysts, who work together to deliver tailored solutions to their clients.
They support companies by providing them with suitable strategic buyers, and support companies actively looking to expand via acquisition. Using their connections and research specialists, they can identify suitable financial partners to support the planned transformation and growth for businesses.
The firm's services range from strategic planning and market research to product development and regulatory compliance. They have a proven track record of helping clients optimise their operations, improve their products and services, and expand their market reach.
The Role:
Based in Thatcham, Berkshire as a Quality and Regulatory Assistant, you will support the Quality and Regulatory Officer in maintaining an accurate and effective Integrated Management System in accordance with medical standards.
Your responsibilities will include:
1. Supporting the Quality Manger with IMS document completion and online record storage in accordance with ISO13485 and ISO 9001 and ISO 14001
2. Assisting with the Non-conformance process and ensuring target deadlines are met
3. Performing the approval process for new and amended Standard Operating Procedures, ensuring new and superseded documentation is correctly filed
4. Liaising with potential suppliers, customers and distributors, obtaining relevant approval information and auditing where necessary to ensure quality standards are met
5. Supporting managers with Training records
6. Monitoring the manufacturing process and ensuring safety of the devices
7. Assisting with devices technical files and ensuring records are updated accordingly
8. Data collection from QMS and analysis to aid continuous improvement
9. Collaborate with UK sales team and overseas partners to gain post-market feedback
10. Gather information and review PMS report periodically
11. Assisting with Internal Audit organisation and reporting
12. Administration tasks in relation to UK Responsible Person service
13. Any other relevant, reasonable ad hoc duties that may be requested
About You:
14. A Degree in any relevant scientific discipline
15. A high level of attention to detail and ability to follow procedures accurately
16. Excellent written and verbal communication skills
17. Highly organised and able to work alone when required
18. Proficient with Microsoft Office (Excel, Word, PowerPoint, Outlook)
19. Maths and English Language A level, preferably grade B or above
20. Previous experience in quality management or regulatory affairs is desirable
21. An ambition to develop a career in a QARA function in the medical device industry
22. Experience with medical devices is highly desirable
Company Benefits:
23. Professional development within the industry
24. Benefits package
25. Friendly and warm team with company social events