Senior Regulatory Affairs Specialist

Recruiter
HERO Recruitment
Employment Type
Permanent
Salary
€60,000 - €61,000 per annum
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Senior Regulatory Affairs Specialist – Hybrid
Permanent role
Limerick

Finding the right company that aligns to your career aspirations and values is so important.

I have a superb opportunity with a global diagnostics/ life science client with a base in to take on the role of Senior Regulatory Affairs Specialist working with the latest technologies across a broad portfolio of products which includes programmable electrical medical devices, stand-alone software as medical device, accessories and disposable infusion sets. This is a highly visible role within the organisation, and you will participate in multi-functional teams as the regulatory expert (e.g. 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.

Responsibilities

  • Inputting into development of regulatory strategies and providing guidance and expertise.
  • Compiling and communicating regulatory requirements (e.g. EU MDR, global markets, standards, etc.) to multi-functional groups in a concise and precise manner.
  • Maintaining Regulatory procedures to ensure continued compliance
  • Preparing and presenting gap analysis assessments of regulations, and guiding peers and multi-functional groups in a concise and precise manner.
  • Review and approve 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.
  • Mentor and develop team members.

Requirements

  • For this role you will hold a relevant degree (BSC in Electronics or Biomedical engineering discipline), or equivalent proven experience
  • 2+ years’ experience in a similar position.
  • You will have worked with regulatory submissions with exposure to mechanical and active devices (stand-alone softwares, instruments and disposable devices) and mobile applications.
  • Knowledge and experience on EU MDR / UK MDR / EU MDD / MDSAP and standards (ISO 13485, ISO 14971, IEC 60601 series and IEC 62304) is a plus.

For further information on this role in please contact Elaine Ferguson at or
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