Are you wanting to progress into the next stage of your regulatory career? Do you want to work for one of the top 5 global medical device companies? Our client is looking for a passionate and dedicated person to step into this highly visible Senior Regulatory Affairs Specialist role within the organisation in Limerick.  
 

The company 

Our client is a dominant market leader in providing solutions that improve medical discovery, diagnostics, and delivery of patient care. They have over 70,000 employees worldwide and a presence in almost every country on the planet. Their core focus is on making sure healthcare professionals, pharmaceutical providers and industry partners have the innovative technologies to help advance clinical therapies for patients, clinical processes, and workflow.  

The role 

As a Senior Regulatory Affairs Specialist, you will be working with the latest technologies across a broad portfolio of products. You will look to gain department and platform influence by co-operating in all RA accomplishments and sharing regulatory knowledge and demonstrating compliance with changing global regulations.  

Responsibilities include: 

• Working with programmable electrical medical devices, stand-alone software as medical devices, accessories, and disposable infusion sets 

• Participating in multifunctional teams as the regulatory expert  

• Preparing and presenting gap analysis assessments of regulations 

• Reviewing and approving project documentation 

• Supporting first-to-market commercial opportunities 

• Identifying roadblocks and effectively communicating with your peers 

• Supporting continuous improvement processes 

• Mentoring and developing team members 

The requirements 

You will have a proven track record working in a similar RA position, as well as… 

• You will have worked with regulatory submissions with exposure to mechanical and active devices 

• Exposure to mechanical and active devices  

• Knowledge and experience in EU MDR / UK MDR / EU MDD / MDSAP and standards (ISO 13485, ISO 14971, IEC 60601 series and IEC 62304) 

• Minimum of a bachelor’s degree (BSC in Electronics or Biomedical engineering) 

• This role is Limerick-based with flexible hybrid working (1-2 days per week) 

We can offer VISA sponsorship for this role so will look at candidates outside of the UK looking to relocate. 

Important information 

FMC contact for this role: Natasha Szombara (natasha.szombara@fmctalent.com) 

Reference number: 12387