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 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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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.