Senior Regulatory Affairs Specialist
Recruiter
Listed on
Location
Salary/Rate
Type
This job has now expired please search on the home page to find live IT Jobs.
I am currently working with a leading medical device company located in Athlone.Who have an immediate opening for a Senior Regulatory Affairs Specialist.My client are a growing company with excellent opportunities for progression.
This is a permanent role with excellent salary and benefits.
What will I be doing as a Senior Regulatory Affairs Specialist?
* Complete the regulatory planning activities for the applicable strategic manufacturing projects.
* Clearly communicate regulatory requirements for the strategic manufacturing projects to the project managers and program manager.
* Participate in project meetings to ensure that the teams remain compliant with regulatory requirements during the planning, execution and closure of the projects.
* Lead all communication with the applicable notified body to ensure they effectively schedule resources to facilitate the companies approval timelines and to ensure that they communicate their expectations for the applicable strategic manufacturing project.
* Interface with various departments as applicable for the project to ensure all regulatory deliverables are achieved.
* Transfer technical files to the assigned legal manufacturer and maintain the technical files once transferred.
* Complete risk management and post market surveillance activities to support the technical files at the sending sites until the transfer activities are complete.
* Adhere to and ensure the compliance of the companies Code of Ethics, all company policies, rules, procedures, and housekeeping standards.
What I need to be a Senior Regulatory Affairs Specialist?
* Level 8 degree
* 3-6 years medical device industry experience.
* Technical writing expertise.Extensive knowledge and understanding of US and international medical device regulations, standards and guidance documents.
* Project Management skills and experience and people Management skills and experience.
If you meet the above requirements and are interested in hearing more don't hesitate in apply. Don't miss out on this opportunity to become part of a leading company going through an exciting growth phase. Please respond with an updated CV.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales