Regulatory Affairs Project Manager
As a Regulatory Affairs Project Manager, you will be responsible for leading and directing complex projects within the scope of our Central Economic Operator Team. This role involves managing resources and functional integration across all aspects of the project from initiation to completion.
Key responsibilities include:
* Reviewing technical documentation against EU MDR requirements
* Working with international manufacturing sites to resolve issues
* Posting finalised technical documentation and review checklists to a central repository
* Reporting compliance metrics to senior management
* Escalating regulatory compliance gaps and potential patient safety issues in a timely manner
To succeed in this role, you will need excellent interpersonal communication, collaborative teamwork, and negotiation skills. You will also need to be able to build trusting relationships with mid-level management and clearly convey information to peers, supervisors, and other stakeholders across the organization.
The ideal candidate will have a university degree and at least 4 years' relevant experience, preferably within the medical device industry.