About Your New Employer

You will work as a Principal Regulatory Affairs Specialist for a global medical device company who strive to design and manufacture ground-breaking healthcare technology solutions. You will join a team on their site in Galway on a permanent basis to provide innovative strategies and strategic leadership in the Regulatory Affairs department.

About Your New Job   

As a Regulatory Affairs Specialist you will…

• Direct or perform coordination and preparation of document packages for regulatory submissions.
• Support change control activities to support global approval and implementation of product and process changes.
• Lead or compile all materials required in submissions, license renewal and annual registrations.
• Team with business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
• Recommend changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
• Keep abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements.
• Have direct interaction with regulatory agencies on defined matters.
• Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
• Identify and develop best practices within the Regulatory Affairs Department including continuous development initiatives.

What Skills You Need

• Level 8 Honor’s Degree Science or Engineering bachelor's degree/master's with a minimum of 5 years of relevant experience. A Regulatory Affairs qualification is desirable, but not mandatory.  
• Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated industry is required.

• Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements.
• Previous experience providing guidance, coaching, and training to other employees within job area.

What’s on Offer

• Permanent Job
• Bonus
• Healthcare
• Pension

What’s Next

Apply now by clicking the “Apply Now" button or call me, Lauryn Flanagan on +353 91 455306

Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available.