Description
Are you a self-starter, with the ability to work autonomously and a background in Regulatory Affairs? If the answer is yes, this could be the role for you!
Why you should apply:
This is an exciting oppoortunity to join an established yet growing company, with lots of scope for career progression and a competetive salary & package on offer. What you will be doing:
Champion compliance to applicable Global Regulations and standards ( e.g MDR, IVDR, ISO
etc) Identify products compliant or not with regulatory requirements in our current markets and
liaise with non-compliant potential suppliers. Maintain audit ready product database for customers and HPRA assurance. Maintain organized and up-to-date regulatory files, records, and documentation, ensuring
accessibility and accuracy for internal and external stakeholders. Ensure preparedness and support of regulatory agency audits, inspections, and interactions,
including facilitating document requests, coordinating responses, and addressing findings. Collaborate with cross-functional teams to assess and manage risks associated with products,
processes, and regulatory changes. Implement risk mitigation strategies as needed. Monitor impact of changing evolving global regulations on submissions, guidance documents,
best practices procedures and communicate to internal stakeholders. Drive quality culture in accordance with our quality policies, guidelines and processes Work with the Commercial Team to ensure country specific registration activities are understood and appropriately addressed. Lead Management Review process; report on the performance of the Quality System Manage Design Control, Change Control, CAPA, Risk Management, Product Vigilance and Document Control Systems Lead strategic quality improvement projects and initiatives which enhance the long-term sustainability of the company Evaluate, and authorise, if appropriate, changes to the supply chain processes Lead product and facility inspections, preparation of procedures and instructions including certification assessment and surveillance audits, HPRA, WHO inspections, other regulatory inspections and supplier audits. What you need to apply:
A minimum of 3 years’ experience in a medical device/healthcare industry in a regulatory position. Excellent attention to detail skills and be a "self-starter" in terms of time and task management and be able to operate with minimal supervision. Have a methodical review approach and be capable of initiating and leading change and continuous improvement. Ability to work within a team environment to achieve agreed company goals. Good understanding of ISO, MDD v MDR & CE/UKCA. Analytical mindset and critical thinking Excellent communication and people skills
