Regulatory Affairs Manager
* Co. Limerick
* Multinational Medical Devices organisation
* Continuous Investment for R&D, Innovation and Product Development
Background:
Strive Search are delighted to be partnered with a multinational Medical Devices organisation for the recruitment of a Regulatory Affairs Manager, overseeing a 4 membered team within IVD. This is an excellent opportunity for a candidate with experience in Reg Affairs, looking to step into a management position with autonomy
What's on offer?
* Competitive salary
* Flexible start times with early finish on Fridays
* Opportunity to work within a niche industry in Ireland
Key Responsibilities:
* Lead a 4 membered team with direct reporting.
* Oversee the regulatory strategy implementation
* Manage and maintain technical documentation.
* Manage the internal post-market surveillance and risk management processes.
* Manage regulatory submission timelines, identify risks and appropriate mitigations.
Key Skills Required:
* BSc in Scientific discipline
* Minimum 4 years' experience working in a regulatory affairs related role within Medical Devices or IVD industry.
* At least 1 years' experience mentoring/supervising junior staff members.
* Excellent working knowledge of ISO 13485 and IVDR/MDR.