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 opportunity to join an established yet growing company, with lots of scope for career progression and a competitive 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 authorize, 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.
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