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Regulatory Affairs Specialist

Regulatory Affairs Specialist

ALLPRO-Job-Manager

Website AllPro Recruitment

On behalf of our client, we are seeking a Regulatory Affairs Specialist to join their team in Tullamore, Co Offaly. This is a full-time, permanent position working with a thriving supplier of medical devices and products to a range of clients in the healthcare industry nationally and across Europe.

Description of the Role:

  • Champion compliance to applicable Global Regulations and standards ( 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
  • Manage Notified Body interactions.
  • Manage the regulatory changes related to UKCA and MDR.
  • Manage Regulatory Assessment of any Device / Quality System changes, and any subsequent notifications that are required to be made to Regulatory Agencies.
  • 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
  • ISO Quality Management representative, manage all correspondence with Notified Body in order to achieve certification

Education/Experience:

  • A minimum of 3 years’ experience in a medical device/healthcare industry in a regulatory position.
  • Excellent verbal and written communication skills.
  • Excellent attention to detail skills.
  • Must 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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