Risk Management Specialist
If you are a risk management professional with knowledge of ISO 14971, this is an exceptional opportunity to develop your career with a dynamic medical devices provider.
Established in 1999, Medtrade Products Ltd is an innovative developer and manufacturer of wound and healthcare solutions.
We are currently looking for a Risk Management Specialist to join our hard-working team in Crewe.
As the Risk Management Specialist, you will maintain and implement post-launch risk management processes for our range of medical devices.
Working in line with global regulatory requirements, you’ll ensure that risks are effectively identified and mitigated.
You’ll oversee the preparation of risk management plans and reports in line with ISO 14971 standards and maintain the risk management files for post-market products.
Additionally, you will support post-market risk management system activities and collaborate with cross-functional teams to facilitate continuous improvement initiatives.
To join us as a Risk Management Specialist, you’ll need:
- Risk management experience, ideally gained in the medical device industry
- Experience of working in a regulated environment
- In-depth knowledge of ISO 14971
- Knowledge of relevant GMP and quality system standards, specifically FDA Quality System Regulation and ISO 13485
- An understanding of the European Medical Devices Regulations (MDR) relevant to this role
- A degree (or equivalent qualification) in a life science-related discipline, or equivalent industry experience
Other organisations may call this role Risk Manager, Risk & Compliance Manager, Compliance Manager, Medical Devices Risk Manager, Medical Devices Compliance Manager, Senior Risk Management Officer, or Senior Risk & Compliance Officer.
- Competitive salary
- Auto-enrolment pension scheme (3% employee contribution, 6% employer contribution)
- 25 days’ holiday plus eight public holidays
- 4 x life insurance
Webrecruit and Medtrade Products Ltd are equal opportunities employers, value diversity and are strongly committed to providing equal employment opportunities for all employees and all applicants for employment. Equal opportunities are the only acceptable way to conduct business and we believe that the more inclusive our environments are, the better our work will be.
So, if you’re seeking your next challenge as a Risk Management Specialist, please apply via the button shown. This vacancy is being advertised by Webrecruit. The services advertised by Webrecruit are those of an Employment Agency.
Working hours: 37.5 hours per week, Monday – Friday, with a 30 minute lunch
Risk Management Specialist