Our client a major multinational based here in Galway are seeking applications from a Senior Regulatory Affairs Specialist to join them.
The Role:
As the Senior Regulatory Affairs Specialist you will be responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations. You must also ensure continued compliance with regulatory agency approvals including change impact reviews. You will also be expected to participate in cross functional teams as the regulatory expert (e.g. new product development projects, sustaining engineering projects, MDR compliance program).
Responsibilities:
- Collaborates with cross functional stakeholders to ensure regulatory compliance is maintained and regulatory deliverables are achieved with specific responsibility for Coronary Therapy devices.
- Provide Technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy and clarity of presentation.
- Coordinates, compiles and submits U.S. and EU regulatory applications for new and modified products, including PMA supplements, CE Marking submissions, as well as maintaining internal regulatory file documentation.
- Acts as a core team member on new product development teams, providing regulatory strategy and guidance throughout the product development cycle, and coordinating team inputs for global submissions.
- Reviews and approves design and manufacturing changes for existing approved products, ensuring compliance with applicable regulations.
- Supports international geographies to gain and maintain product approvals.
- Fosters a work environment of continuous improvement in relation to the Quality Policy, Quality System and the appropriate regulations for their area of responsibility.
- Supports efforts to continuously improve department and divisional processes/practices, including collaboration, best practices, and knowledge sharing.
- Understand and implement the Product Lifecycle processes in particular post-market support activities.
- Participates in Regulatory Body audits such as FDA, DEKRA, HPRA.
Requirements:
- Education: Level 8 HETAC qualification in Science/Engineering discipline or equivalent experience (240 credits)
- Experience: Level 8 with +4 years Regulatory Affairs Experience supporting medical devices and/or drug-device combination products.
- Team player with excellent interpersonal skills.
- Excellent verbal and technical writing skills.
- Self-motivated with a proactive attitude and the ability to work independently
- Demonstrated ability to effectively manage multiple projects and priorities
- Advanced knowledge of the European Medical Devices Regulation (EU) 2017/745 and associated guidance documents (eg: MDCG Guidance Documents) and Quality Management System requirements (i.e. ISO 13485)
- Experience in directly engaging with Health Authorities (eg: Pre-submission meetings, responses to regulatory information submission requests.)
- Previous experience within Regulatory Affairs, regulating Class III combination devices, with knowledge of US FDA regulations on medical device and combination products.
- Knowledge of EU and US medicinal product (including drug led combination products) regulatory submission requirements (e.g. MAA, NDA, ANDA) would be an advantage.
For more information or a confidential discussion about this role please contact Michelle McInerney
michelle.mcinerney@collinsmcnicholas.ie
091 706 717