Regulatory Specialist

1 week ago

Cork, Ireland TEAM HORIZON Full time

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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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