Our client, a medical device company in Limerick is currently looking to recruit a Regulatory Affairs Specialist for their site.
The staff 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).
- Develops 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.
- Reviews and approves the project documentation (design reports, labelling, etc.).
- Ensures that updates to the Technical Files and international registrations are conducted appropriately.
- Develops tactics supporting first to market commercial opportunities, and minimizes time to product launch.
- Works closely with the other functions (QA, R&D, Medical Affairs…) to ensure that all regulatory requirements are effectively addressed within the documentation, the processes and the Technical Documentation.
- Identifies roadblocks, defines problems based on data / facts and effectively communicates with his/her peers, project teams or management (as appropriate) for seeking solutions.
- Supports continuous improvements in regulatory processes, QMS processes or company-wide initiatives.
- BSC in Electronics or Biomedical engineering discipline, or equivalent proven experience.
- Minimum of 7 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.
- Knowledge of software, instrument and disposable design practices.
- Experience with representing Regulatory Affairs in multiple environments (i.e. R&D, operations, marketing, medical affairs, etc.)
- Demonstrated analytical and planning skills, together with the ability to take decisions and to translate those decisions into actions and priorities;
- Demonstrate interpersonal skills including strong communication and negotiation skills;
- Cultural sensitivity, open-mindedness and flexibility to work effectively in a dynamic multinational, matrix organisation;
- Continuous improvement driven: Detects significant opportunities for improvement (cost, cycle time, process, quality, etc.). Analyses feasibility, participates and possibly leads in developing, executing, or monitoring implementation plan demonstrating strategic thinking as well as attention to detail.
- Open to travel (EU and outside EU).
For further information on this Regulatory Affairs Specialist role in Limerick please contact Bimi Felix on 086 8395533 / email@example.com
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