Our Client based here in Galway are looking to hire a Senior Regulatory Affairs Specialist.
This is a permanent role offering a generous salary and benefits package as well as hybrid working.
As the Senior Regulatory Affairs Specialist you will work on innovative strategies for regulatory approval, anticipate and respond to changing regulatory requirements, and provide strategic leadership to influence the global regulatory environment.
- Directs or performs coordination and preparation of document packages for regulatory submissions. Supports change control activities to support global approval and implementation of product and process changes.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Teams with business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
- Recommends changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
- Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements.
- May have direct interaction with regulatory agencies on defined matters.
- Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
- Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.
- Level 8 Honor’s Degree Science or Engineering bachelor's degree/master's with a minimum of 5 years of relevant experience.
- Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated industry is required. You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
- You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
- Ability to comprehend principles of engineering, physiology, and medical device use.
- You collaborate with global cross functional teams and create alignment with team members. Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements.
- May provide guidance, coaching and training to other employees within job area.
- You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behaviour.
- Ability to effectively manage multiple projects and priorities.
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.
091 706 717