Regulatory Affairs Specialist - Med Dev
Summary of role
Our client, a leading medical device company in Limerick are seeking an experienced Regulatory Affairs Specialist to join their team. This is a newly created position which has come available due to the increase in workload. Within this position you will be required to work alongside the Senior Regulatory Affairs Specialist managing a broad portfolio of products including infusion pumps (Programmable Electrical Medical Devices), stand-alone software as medical device, and disposable infusion sets.
**This is an live vacancy with interviews being held ASAP**
Essential requirements summarised
The successful candidate will have a degree Electronics or Biomedical Engineering and have a minimum of 2+ years' experience within Regulatory Affairs within the medical device industry with exposure to programmable electrical equipment. You will be knowledgeable on EU MDR / EU MDD and ISO Standards, with knowledge on FDA and NMPA regulatory requirements a plus.
The RA specialist drives and/or 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.
For a confidential discussion contact Kerry on 086 044 3981