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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)
* 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 the impact of changing global regulations on submissions, guidance documents, and best practices; communicate updates to internal stakeholders.
* Drive a 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 the 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 to enhance the company's long-term sustainability.
* Evaluate and, if appropriate, authorize changes to the supply chain processes.
* Lead product and facility inspections, including preparation of procedures and instructions, certification assessments, surveillance audits, and regulatory inspections (HPRA, WHO, others) 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, self-motivated, and capable of managing time and tasks independently.
* Methodical review approach, capable of initiating and leading change and continuous improvement.
* Ability to work within a team to achieve company goals.
* Good understanding of ISO, MDD, MDR, CE/UKCA standards.
* Analytical mindset and critical thinking skills.
* Excellent communication and interpersonal skills.
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