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Job ID: JOB-13468

Senior Regulatory Affairs Specialist

Limerick (Hybrid)

Our Limerick based Client, a global leader in R&D are hiring for their facility in Limerick.

In this role, the Senior Regulatory Affairs Specialist will be working with our Client’s 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

A Day in the life…

• Inputting into development of regulatory strategies and providing guidance and expertise.
• Compiling and communicating 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 approve 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.
• Mentor and develop team members.

About you..

• For this role you will hold a relevant degree (BSC in Electronics or Biomedical engineering discipline), or equivalent proven experience and have 2+ years’ experience in a similar position.
• You will have worked with regulatory submissions with exposure to mechanical and active devices (stand-alone softwares, instruments and disposable devices) and mobile applications.
• Knowledge and experience on EU MDR / UK MDR / EU MDD / MDSAP and standards(ISO 13485, ISO 14971, IEC 60601 series and IEC 62304…) is a plus.

For further information on this role in Limerick please contact Mark Wilson on 0860449473 or email talent@hero.ie

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

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

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.

Mark Wilson

JOB-13468

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