Title: Product Development Project Manager
Job Type: 12 months contract
Salary: The PAYE rate is £45.87 per hour
Contact Person: Miss Rashida Khan
Opportunity: Have you project managed medical device projects related to regulatory affairs, design assurance, risk management and Design History Files remediation? Do you have experience of the new European Medical Device Regulation (MDR)? Looking for a long term contract role based working from home with an exciting global medical device company? If yes then this is the role for you.
Your role as a Medical Device Product Development Project Manager based working from home will involve working on medical device products (mainly class 3) performing tasks related to regulatory compliance, change control, design control and risk management.
Duties and responsibilities include:
- Leading the activities required in the design and development assurance and documentation to maintain regulatory compliance for medical devices, particularly for the new European Medical Device Regulation (MDR).
- Reviewing and executing regulatory gap assessments against existing and new regulations.
- Maintaining and remediating Design History Files and Risk Management files for medical devices.
- Generating and managing the work flow for appropriate change control documentation.
- Project managing medical device projects related to design assurance, risk management and DHF remediation.
This is a 12 months contract role which will be reviewed for a possible extension but everything is dependent on the individual and business performance. This is a homebased role but you do have the option to work at the site in Hertfordshire.
The PAYE rate is £45.87 per hour.
Skills: To apply for the role of Medical Device Product Development Project Manager you will have the following:
- Educated to degree level (a scientific/engineering degree).
- Experience in carrying out the above duties.
- Knowledge and experience working with medical device regulatory requirements, design control, change control, and risk management.
- Experience with the new European Medical Device Regulation (MDR).