Description
I'm working with a Medical Device company in Cambridge who are looking for a consultant to put together a PMA submission for one of their existing CE marked products. Whilst a medical device in Europe, the FDA have decided that it will be classed as a combination product with a device primary mode of action.What they are looking for:
- PMA submission experience
- Combination product experience…particularly with a device primary mode of action
- Prepared to get stuck in and prepare documentation, rather than just reviewing. There is some resource available for document writing, but they are still very lean
- Willingness to spend a reasonable proportion of time on site in Cambridge
- Somebody who can drive the whole process: define work packages, set and deliver to timescales etc
Skills & Experience:
- 5+ years professional regulatory experience in Medical Device
- Proven Project Management skills
- Solid knowledge of US Medical Device regulatory framework and associated FDA guidance
- Significant operational experience with Medical Device technical standards (ISO 14971, etc.
- Ability to manage multiple projects and deadlines, monitor workload and prioritize
- Successful at time management and proven ability to meet deadlines
- Strong written and verbal communication, presentation, and facilitation skills
- Ability to work remotely (position could be partially home-based envisaged)