Our client a medical device company in Limerick is looking to hire a Regulatory Affairs Specialist for their site.
The RA specialist drives and supports key MMS projects in which regulatory affairs is a critical component or 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.
It combines knowledge of scientific, regulatory and business acumen to ensure that products are developed, manufactured and distributed in compliance with applicable regulatory requirements and standards.
This function exhibits a high degree of independent judgment and execute on plans that directly impact the operational results of the business unit.
The RA specialist supports a broad range of projects for infusion pumps, embedded or stand-alone software, pump accessories or infusion sets. He/she participates 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 in a concise and precise manner.
- 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 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 13485, ISO 14971 and IEC 60601 series...); knowledge of FDA regulatory requirements is a plus.
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