The Role:
PE Global is currently recruiting for a Senior Regulatory Affairs Specialist on behalf of a leading medical device company based in Galway. This is an initial 12-month contract role.
Key Responsibilities:
* Coordinates and prepares document packages for regulatory submissions.
* Supports change control activities to secure global approval and implementation of product and process changes.
* Leads the compilation of materials required for submissions, license renewals, and annual registrations.
* Collaborates with Regulatory Affairs Specialists and international regulatory staff to provide regulatory support.
* Works with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
* Recommends changes for labeling and internal documentation, ensuring regulatory compliance.
* Remains up-to-date on regulatory procedures and changes, supporting reviews of internal procedures to ensure ongoing compliance.
* May interact directly with regulatory agencies on defined matters.
* Supports regulatory compliance activities, including manufacturing site registration and GMP audits as needed.
* Identifies and develops 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' relevant experience, preferably in Class III devices.
* Regulatory experience in Medical Devices, Pharmaceuticals, Software, or similar regulated industries.
* A dynamic team player who can work effectively and proactively on activities both individually and in teams.
* Strong technical knowledge and critical thinking skills, with the ability to make sound decisions.
* Collaborative mindset, with experience working with global cross-functional teams and creating alignment with team members.
* Knowledge of FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745, and international regulatory agency requirements.
* Ability to provide guidance, coaching, and training to other employees within the job area.