Quality Manager, Regulatory, Medical Device, ISO 13485

Recruiter
Confidential
Location
Cambridge
Salary
45000.00 - 55000.00 GBP Annual + Benefits
Posted
21 May 2021
Closes
18 Jun 2021
Contract Type
Permanent
Hours
Full Time
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!

The role

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

The Company

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.

What's Required?

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

What Next?

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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