Quality Manager, Regulatory, Medical Device, ISO 13485
Are you a Quality Manager / Regulatory Assurance Manager seeking your next position? Do you have proven experience with Medical devices and a strong knowledge of ISO13485? Are you keen to join a company who are truly making a difference? If so, this could be the position for you!
My client, an innovative Med-tech organisation are seeking a skilled Quality Manager / Regulatory Assurance Manager to join their team on a fully remote basis. The successful candidate will work alongside technical teams, and a Regulatory consultancy, in order to contribute to the development and improvement of company products, providing sound regulatory input. As well as this, the Quality Manager / Regulatory Assurance Manager will:
- Plan and execute clinical evaluation initiatives
- Liaise with global authorities within the regulatory field, relating to the company's QMS & product certificate
- Assist in the maintenance of the company's QMS
- Observe & report on Quality aims and KPIs
As the successful Quality Manager / Regulatory Assurance Manager, you will be joining a collaborative start-up work environment, which is rapidly growing. Their products play a pivotal role within patient healthcare and have an impact on lives, particularly within the current climate! The company are able to offer flexible working, both in terms of remote working and work hours.
Joining this team as the Quality Manager / Regulatory Assurance Manager will require a resilient can-do attitude, for someone keen to make a real difference day-to day. You will be someone who doesn't shy away from a challenge but embraces it instead, and as well as having these softer skills, the successful Quality Manager / Regulatory Assurance Manager will ideally have:
- A relevant degree, HND or similar such as a STEM degree
- Commercial experience within quality / regulatory management of medical devices
- Experience of maintaining an ISO 13485 Quality Management System
- Experience in compiling technical documentation for medical devices
- Prior knowledge of the EU CE marking process for medical devices or US FDA product approval process is highly desirable
If you think that the above spec matches your skills and you are a Quality Manager / Regulatory Assurance Manager in search of your next opportunity apply now for immediate consideration! Alternatively, if you are still unsure and have any questions just call me or drop me an email, as I would love to hear from you!
Quality Manager, Regulatory Manager, Medical Device, ISO 13485, ISO9001, Remote
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