Description
Senior Quality Assurance & Regulatory Affairs Manager is required to manage all QA/RA requirements for a global medical device manufacturer. The role requires a dynamic, hard-working professional with a solid education and background in managing.Challenging responsibilities include:
* Manage product evaluation from a quality assurance and regulation compliance standpoint.
* Manage and implement the division in the planning of the design, testing, inspection and process validations to assure quality products or components.
* Developing SOPs and procedures to maintain high quality standards.
* Communicating significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
* Prepare reports to communicate involvement and results of quality assurance activities.
* Prepare and present technical and program information to team members and management.
Qualifications
Requirements for the opportunity include:
* 7-10 years quality and/or regulatory experience in the medical device industry including European Medical Device Directive (MDD) & FDA 510(k) submissions.
* Strong work ethic - highly motivated, inspirational leader, who is able to self-train and manage.
* Excellent written and verbal communications.
* Project management skills and the ability to manage multiple priorities.
If you think you have the relevant experience for the role then please send through your updated CV to Oliver Davies.
For more information on the above role please follow the link https://uk.linkedin.com/in/medicaldevicesqara