The RA specialist drives / supports key MMS projects in which regulatory affairs is a critical component component of driver. This role applies to a broad portfolio of products including Infusion Pumps (Programmable Electrical Medical Devices), stand-alone software as medical device, and disposable infusion sets. This role is full-time, permanent and is based in Limerick.
As the RA Specialist you will have:
- Inputs to development of regulatory strategies and provides guidance and expertise
- Complies and communicates regulatory requirement (e.g MMD / MDR, standards etc.) to cross-functional groups in a concise and precise manner
- Prepares and presents gap analysis assessments of regulations and guidance’s to peers and cross-functional groups in a concise and precise manner
- Review and approves the project documentation (design reports, labelling etc.)
- Develop tactics supporting first to market commercial opportunities and minimizes time to product launch
The successful candidate will have:
- BSC in Electronics or Biomedical engineering discipline, or equivalent proven experience
- Minimum of 3 years’ experience in Regulatory Affairs within medical devices industry with exposure to programmable Electrical equipment.
- Alternatively, a strong technical experience in the field of Programmable Electrical Medical Systems including exposure to regulatory affairs requirements.
- Knowledge and experience on EU MDR / EU MDD and standards (ISO and IEC
- Knowledge of FDA regulatory requirements is a plus
If you would like to discuss this role, please reach out to Louise Whitty on 021 2359140 / firstname.lastname@example.org
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