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Regulatory Affairs Specialist

Job description

Purpose

This role will focus on complaint handling and post market regulatory reporting activities for a wide range of medical device products.

As a Regulatory Affairs Vigilance Specialist, you will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting (MDR) and Vigilance compliance. 

Responsibilities

-      Ensuring that statutory Regulatory Obligations under the Medical Device Vigilance requirements of the Medical Device Directive (MDD) within the EEA are met.

-      You will be responsible for the timely Submission of EU Vigilance Reports to external regulatory agencies in order to maintain regulatory compliance.

-      You must be able to Liaise and Communicate effectively within the company and relevant bodies.

-      Perform Vigilance tasks effectively.

-      You will contribute to Continuous Improvement activities and problem-solving initiatives within the department.

 

Qualifications

-      A third level Degree in a relevant area

-      Experience of working within a Highly Regulated Environment (preferably healthcare) and experience in communicating with government or statutory authorities.

-      A dynamic Team Player who can work effectively and proactively on cross-functional teams.

-      Experience/understanding of Complaint Handling or CAPA processes are desirable.

 

To apply for this position please contact Amanda Reynolds at Sigmar Recruitment T: +353 91 455304 E: areynolds@sigmar.ie

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

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