Regulatory Affairs Manager is required to act as a regulatory expert within our medical technology client’s engineering team in Limerick. Our client is looking for the next Quality SME who will participate in multi-functional teams as the regulatory expert in new product development projects, sustaining engineering projects, MDR compliance program, etc. The role will work closely with the other functions (QA, R&D, Medical Affairs, etc.) to ensure that all regulatory requirements are effectively addressed within the documentation, the processes and the Technical Documentation and that any direct reports are well supported and empowered.

Responsibilities:

  • Maintaining Regulatory procedures to ensure continued compliance
  • Manage and deliver on NPD and sustaining projects.
  • Inputting into development of regulatory strategies and providing guidance and expertise.
  • Responsible for delivery and reporting on function KPIs.
  • Ensure compiling and communicating of regulatory requirements (e.g. EU MDR, global markets, standards, etc.) to multi-functional groups in a concise and precise manner.
  • Preparing and presenting gap analysis assessments of regulations.
  • Review and approval of relevant the project documentation (design reports, labelling, etc.).
  • Ensure that updates to the Technical Files and international registrations are conducted appropriately.
  • Develop tactics to support first to market commercial opportunities and minimising time to product launch.
  • Work closely with the other functions (QA, R&D, Medical Affairs, etc.) to ensure that all regulatory requirements are effectively addressed within the documentation, the processes and the Technical Documentation.
  • Identify roadblocks, defining problems based on data / facts and effectively communicating with your peers, project teams or management (as appropriate) for seeking solutions.
  • Support continuous improvements in regulatory processes, QMS processes or company-wide initiatives.
  • Supervision, mentoring and professional development of direct reports.
  • Open to travel to other sites to support teams and project goals.

Requirements: 

  • Bachelor’s Degree or higher in Electronics or Biomedical engineering discipline, or similar.
  • A minimum of 3 years’ experience in a similar role managing teams.
  • Proven experience with regulatory submissions with exposure to mechanical and active devices (stand-alone software’s, instruments and disposable devices) and mobile applications.
  • Knowledge and experience on EU MDR / UK MDR / MDSAP / US 21 CFR 820 and supporting standards is a plus.

Our client offers an exciting work culture with opportunity for career growth as well as benefits such as: Pension, Health insurance, Death in Service Benefit, Sick pay scheme,  Educational assistance, Annual Leave, etc. 

Please send you CV in confidence to emer@emtechrecruitment.ie

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