Regulatory Affairs Manager

Job type:
Real Staffing
flag_no United Kingdom

Project description:
This project is archived and not active any more.
You will find vacant projects in our project database.
I am currently recruiting for a Medical Device, Regulatory Affairs Manager. The principle responsibilities for the correct Regulatory Affairs candidate will be to:

* Develop regulatory strategies and associated plans to address commercial needs

* Work with the project team in the preparation and delivery of a detailed plan of regulatory and supporting activities in order to achieve regulatory submissions to time and budget

* Advise corporate project teams on regulatory requirements and registration strategies.

* Ensure that the resources required to support regulatory submissions are adequately defined and costed in the project budget(s)

* Liaise with regulatory agencies globally to achieve successful outcomes from face to face meetings (including EU and US).

To be considered for the role you will require;

* A minimum of 6-8 years industry experience, including 5 years + of Global Medical Device Regulatory Affairs experience

* Knowledge and understanding of applicable international regulations particularly those relevant to medical devices and combination products. Understand application of medical device cGMP systems particularly US 21 CFR pts 4 and 820 and ISO 13485

* Strong analytical abilities

* Strategic thinking, leadership and ability to apply risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and communicate these effectively.

* Excellent communication and influencing skills internally and externally at all levels of the organization, including colleagues in different locations and different countries

* Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff

* Effective cross functional and cross cultural skills including influence at external industry meetings

For more information on the role send through your up to date CV to Oliver Davies or call

For further details on the above role, please follow the hyperlink attached;