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Job ID: JOB-13470
Regulatory Affairs Manager

Tired of feeling undervalued in Regulatory Affairs Join this leading company in Limerick and you will feel the difference. Join a growing company who values their people. Our client is an exceptional company who offer their Regulatory Affair Managers top salaries and benefits! If you’re applying for a mortgage, where salary and benefits are key, this is a must job to explore. Let’s have a conversation to see if this is right for you.

Purpose

In this role, the Manager – Regulatory Affairs will be working with the latest technologies across a broad portfolio of products which includes programmable electrical medical devices, stand-alone software as medical device, accessories and disposable infusion sets. This is a highly visible role within the organization, and you will participate in multi-functional teams as the regulatory expert (e.g. new product development projects, sustaining engineering projects, MDR compliance program, etc.). The role will work closely with the other functions (QA, R&D, Medical Affairs, etc.) to ensure that all regulatory requirements are effectively addressed within the documentation, the processes and the Technical Documentation and that any direct reports are well supported and empowered

Key Responsibilities

• Management of a geographically distributed team of direct reports, delivering on NPD and sustaining projects.
• Willing to travel to other sites to support teams and project goals.
• Responsible for delivery and reporting on function KPIs.
• Inputting into development of regulatory strategies and providing guidance and expertise.
• Ensure compiling and communicating of regulatory requirements (e.g. EU MDR, global markets, standards, etc.) to multi-functional groups in a concise and precise manner.
• Maintaining Regulatory procedures to ensure continued compliance
• Preparing and presenting gap analysis assessments of regulations, and guiding peers and multi-functional groups in a concise and precise manner.
• Review and approval of relevant the project documentation (design reports, labelling, etc.).
• Ensure that updates to the Technical Files and international registrations are conducted appropriately.
• Develop tactics to support first to market commercial opportunities and minimising time to product launch.
• Work closely with the other functions (QA, R&D, Medical Affairs, etc.) to ensure that all regulatory requirements are effectively addressed within the documentation, the processes and the Technical Documentation.
• Identify roadblocks, defining problems based on data / facts and effectively communicating with your peers, project teams or management (as appropriate) for seeking solutions.
• Support continuous improvements in regulatory processes, QMS processes or company-wide initiatives.
• Supervision, mentoring and professional development of direct reports

Key Qualifications

• Hold a relevant degree (BSC in Electronics or Biomedical engineering discipline), or equivalent proven experience.
• 3+ years’ experience in a similar position managing teams .
• You will have worked with regulatory submissions with exposure to mechanical and active devices (stand-alone software’s, instruments and disposable devices) and mobile applications.
• Knowledge and experience on EU MDR / UK MDR / MDSAP / US 21 CFR 820 and supporting standards is a plus

For further information on this role in Limerick please contact Aisling Kidney on 0872197421 or careers@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Aisling Kidney

JOB-13470

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