Medical Device Documentation Control
An exciting new opportunity has become available for a Medical Device Documentation Controller foray market leading pharmaceutical and medical device firm. Candidate's responsibilities will be to manage and support product documentation processes for medical devices sector.
- Development of document processes for the Design History File, Labelling, Protocols and Product Change Control
- Manage all medical documentation processes
- Participating in design development and design reviews
- Conduct audits of Design History Files, Protocol files, and document change controls to ensure compliance with SOP's and regulatory requirements
- Develop and manage processes for CAD database change control
- Contributing to the development team's successful submission and support of medical devices and combination products
- Adhere to company policies on environmental, health, safety and workplace policies
- Ensure compliance with all local laws regulating commercial activities and that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with company values.
- Carry out other reasonable tasks as require by the Line Manager.
Education and Experience;
- Bachelors degree in mechanical engineering, sciences or equivalent
- Minimum of 5 years of expereince in medical device development
- Demonstrated background of successful product development project management
- Experience with EU and FDA regulatory device requirements
If you are interested in this role, have any questions about this position or would like to register your interest in other positions, please feel free to send your up to date CV or contact me on 0207 758 7322
To find out more about Real Staffing please visit www.realstaffing.com