Job Description
Walker Cole is looking for Regulatory Affairs Specialist to join an exciting fast-growing medical device company with international scope based in Northern Ireland.
As a Regulatory Affairs Specialist you will be:
* Assisting in maintenance of technical files, including creation and control of documentation.
* Support transition from MDD to MDR where required.
* Liaise with departments to support Regulatory activities.
* Implement actions as directed by Regulatory Managers, including in support of Engineering Changes.
* Support teams during external and internal audits.
* Support in global registration activities.
* Work with technical documentation within electronic document management systems.
A Regulatory Affairs Specialist will have:
* Experience within Medical Devices or a related area.
* Understanding of the Regulatory Profession.
* Teamwork and great oral and written communication skills.
* Experience working with Microsoft, Acrobat Pro.
Desirable skills of a Regulatory Affairs Specialist:
* Experience of ISO13485
* Understanding of 21 CFR p820, MDD and/or MDR
* Experience of document management and/or ERP systems.
Regulatory Affairs // Specialist // MDD // MDR // Medical Device // ISO13485 // 21 CFR