Senior Regulatory Affairs Specialist, Galway
Our client, a multinational based in Galway, Ireland, is seeking a Senior Regulatory Affairs Specialist for an initial 12-month contract.
Responsibilities:
* We are looking for a professional to direct and perform coordination and preparation of document packages for regulatory submissions.
* You will support change control activities to ensure global approval and implementation of product and process changes.
* The ideal candidate will lead or compile all materials required in submissions, license renewal, and annual registrations.
* This role involves teamwork with business unit Regulatory Affairs Specialists and international regulatory staff to provide regulatory support.
* You will work closely with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
* We require someone who can recommend changes for labeling and internal documentation, reports for regulatory compliance.
* Staying up-to-date with regulatory procedures and changes is essential for this position.
* This role may involve direct interaction with regulatory agencies on defined matters.
* Supporting regulatory compliance activities, including manufacturing site registration & GMP audits as needed, is also part of the job.
* We are looking for someone who can identify and develop best practices within the Regulatory Affairs Department, including continuous development initiatives.
Requirements:
* A Level 8 Honor's Degree in Science or Engineering, with a minimum of 5 years of relevant experience, preferably with Class III devices.
* Regulatory experience in Medical Devices, Pharmaceuticals, Software in a medical device or similar regulated industry is required.
* We are looking for a dynamic team player who can work effectively and pro-actively on activities both individually and in teams.
* Strong technical knowledge is necessary for this role.
* The ideal candidate should be able to comprehend principles of engineering, physiology, and medical device use.
* This role involves collaboration with global cross-functional teams and creating alignment with team members.
* Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements is essential.
* May provide guidance, coaching, and training to other employees within the job area.