Regulatory Specialist

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