Science

RA Manager

  • TypePermanent
  • SalaryNegotiable
  • LocationLimerick
  • Published8 Mar 2023
  • Ref#BBBH12529
  • Apply now!

Azon is delighted to be partnering with a multinational medical device company that works to improve the world of health by improving the delivery of care, diagnostic and medical discoveries. The successful candidate will ensure the regulatory requirements for products such as programmable electrical medical devices, stand-alone software as medical devices, accessories and disposable infusion sets are met and will be responsible for supervising and mentoring direct reports.

Location: Limerick

Main responsibilities:

  • Travel to other sites globally to support teams and project goals.
  • Develop regulatory strategies.
  • Compile and communicate regulatory requirements to multi-functional groups in a concise and precise manner.
  • Maintain regulatory procedures to ensure continued compliance.
  • Prepare and present gap analysis assessments of regulations.
  • Ensure that updates to the Technical Files and international registrations are conducted appropriately.
  • Identify roadblocks, defining problems based on data/facts and effectively communicating with peers, project teams or management for seeking solutions.
  • Support continuous improvements in regulatory processes, QMS processes or company-wide initiatives.

Requirements

  • A relevant degree (BSc in Electronics or Biomedical engineering discipline), or equivalent proven experience.
  • 3+ years’ experience in a similar position managing teams .
  • Experience 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.

Lisa Jeyacheya

Senior Recruitment Consultant - Life Sciences

Lisa, based in our Dublin office is a Senior Recruitment Consultant and specialises in all things Quality Assurance and Regulatory Affairs. She holds a BSc in Nutraceuticals in Health and Nutrition from Technological University Dublin. Lisa has experience as a Medical Laboratory Aide and Medical Laboratory Technician. From here, Lisa moved into recruitment where she focuses on Quality and Regulatory based roles for the Pharma/Biopharma and Medical Device industries.

Apply Now

By submitting this application I consent to my data being used as outlined our Privacy Policy.


DROP YOUR CV HERE OR UPLOAD FROM YOUR COMPUTER

I highly recommend working with Natalia both if you are looking for a new role or if you are looking for potential candidates. Natalia worked with me through the recruitment process and always gave brilliant advice. She is one of the best recruiters I’ve ever had the pleasure to work with. I was delighted to receive and accept an offer at the end of the process and can’t wait to get started in my new role. Thanks Natalia!

Conor spent time getting to know our office dynamic and our requirements to ensure that the candidates put forward would be the correct fit for us. The standard of candidates he sourced were good and we remain very happy with our final choice. Conor was of great assistance throughout the whole process and I would strongly recommend him and Azon as a recruitment partner.

Tony knew exactly what would suit me but was keen to explore all options. Tony set up an interview with Cairn Homes almost immediately and was in constant contact about interview times, locations, who I’d be meeting and also the process itself. Tony was on the ball, a pleasure to deal with and I’d highly recommend Tony as a recruitment partner to any business that are looking to expand / develop their workforce.

Nicole was extremely helpful and relentless in her efforts to help, a credit to the Azon recruitment team , thank for all your help.

I highly recommend working with Natalia both if you are looking for a new role or if you are looking for potential candidates. Natalia worked with me through the recruitment process and always gave brilliant advice. She is one of the best recruiters I’ve ever had the pleasure to work with. I was delighted to receive and accept an offer at the end of the process and can’t wait to get started in my new role. Thanks Natalia!

Previous
Next