Quality Assurance

2 weeks ago

Newmarket, United Kingdom Real Staffing Full time

Our client a global manufacturer of medical device products our looking to add a Quality Assurance & Regulatory Affairs Director to the senior management team. An established business operating to ISO 9001:2008 and BS EN 13485:2003 they manufacture productson site and have acquired the intellectual property and manufacturing rights for a portfolio of products used in healthcare facilities worldwide. They have established subsidiaries and associated companies in New Zealand, Hong Kong, China, Italy and branchoperations in Germany and Russia.

**Role**:
**Responsibilities**:

- The Director Quality Assurance & Regulatory Affairs will organise, plan, and direct all Regulatory Affairs and Quality Assurance functions including product registrations, complaint handling and reporting, internal and external auditing of the quality systemsand support R&D and Marketing.
- Develop policies, procedures, and training to ensure efficient and effective operation of the Company quality system and regulatory requirements.
- Ensure that all products placed on the market meet the requirements of the QMS, that regulatory requirements are met, improve and facilitate the understanding and use of the QMS within the Company.
- Report to the MD the effectiveness of the QMS and any need for improvement.
- Lead business regulatory resources to ensure timely product registrations, regulatory planning for new product introductions
- Product changes, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as CE/UKCA Marking and product registrations.
- Improve regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System.
- accurately reflect the regulatory requirements to aid timely product introductions and/or certificate renewal processes.

**Skills**:

- Understanding of a Quality Management System, and requirements of ISO 13485, Canadian Medical Devices Regulations SOR/98-282, 21 CFR 820 Quality System Regulations, and EU Medical Devices Regulations and 510 (K) requirements.
- Leadership
- Team management and development, promoting culture of compliance and implementing processes that enable it maintaining lean processes.
- Mentoring and coaching both within the Quality Assurance Team and throughout the business to improve the company skillset and understanding of the QMS.

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England andWales

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