The RA specialist will support a broad range of projects for infusion pumps, embedded or stand-alone software, pump accessories or infusion sets. He/she will participate in cross-functional teams as the regulatory expert (e.g. new product development projects, sustaining engineering projects, MDR compliance program, etc).
- Inputs to development of regulatory strategies and provides guidance and expertise.
- Compiles and communicates regulatory requirements (e.g. MDD / 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.
- Reviews and approves the project documentation (design reports, labelling, etc.).
- Develops tactics supporting first to market commercial opportunities and minimizes time to product launch.
- BSC in Electronics or Biomedical engineering discipline, or equivalent proven experience.
- Minimum of 2 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 13485, ISO 14971 and IEC 60601 series).
- Knowledge of FDA regulatory requirements is a plus.
Please note: If you are an EU/EEA national, you will be asked to show proof of right to work e.g. showing your employer a copy of your passport.
If you are a non-EU/EEA national, you will require current and valid permission to work and reside in the EU/EEA. Information on legislation and guides to the procedures in relation to obtaining Green Card Permits, Work Permits, Spousal/Dependent Permits is available on the Department of Jobs, Enterprise, and Innovation website.