Connecting to LinkedIn...

Vacancy Details

Science Pharmaceutical and Food

102823 - Senior Design Assurance Engineer - Limerick

Contract Type: Permanent
Location: Limerick
Date: 15/08/2019
Job Reference: 102823
Contact Name: Bimi Felix
Contact Email:

Job Description

Senior Design Assurance Engineer - Limerick - 102823
Regulatory Affairs Specialist
Our client, a medical device company in Limerick is currently looking to recruit a Regulatory Affairs Specialist for their site.
Job Description
The staff RA specialist drives and/or supports key MMS projects in which regulatory affairs is a critical component or driver. This role applies to a broad portfolio of products including Infusion Pumps (Programmable Electrical Medical Devices), stand-alone software as medical device, and disposable infusion sets. It combines knowledge of scientific, regulatory and business acumen to ensure that products are developed, manufactured and distributed in compliance with applicable regulatory requirements and standards. This function exhibits a high degree of independent judgment and execute on plans that directly impact the operational results of the business unit.

The RA specialist supports a broad range of projects for infusion pumps, embedded or stand-alone software, pump accessories or infusion sets. He/she participates in cross-functional teams as the regulatory expert (e.g. new product development projects, sustaining engineering projects, MDR compliance program, etc).

Main responsibilities:
  • Develops regulatory strategies and provides guidance and expertise.
  • Compiles and communicates regulatory requirements (e.g. MDD / MDR, standards, etc) to cross-functional groups in a concise and precise manner.
  • Reviews and approves the project documentation (design reports, labelling, etc.).
  • Ensures that updates to the Technical Files and international registrations are conducted appropriately.
  • Develops tactics supporting first to market commercial opportunities, and minimizes time to product launch.
  • Works closely with the other functions (QA, R&D, Medical Affairs…) to ensure that all regulatory requirements are effectively addressed within the documentation, the processes and the Technical Documentation.
  • Identifies roadblocks, defines problems based on data / facts and effectively communicates with his/her peers, project teams or management (as appropriate) for seeking solutions.
  • Supports continuous improvements in regulatory processes, QMS processes or company-wide initiatives.
Be Qualified
  • BSC in Electronics or Biomedical engineering discipline, or equivalent proven experience.
  • Minimum of 7 years’ experience in Regulatory Affairs within medical devices industry with exposure to programmable electrical equipment. Alternatively, a strong technical experience in the field of Programmable Electrical Medical Systems including exposure to regulatory affairs requirements;
  • Knowledge and experience on EU MDR / EU MDD and standards (ISO 13485, ISO 14971 and IEC 60601 series…); knowledge of FDA regulatory requirements is a plus.
  • Knowledge of software, instrument and disposable design practices.
  • Experience with representing Regulatory Affairs in multiple environments (i.e. R&D, operations, marketing, medical affairs, etc.)
Skills and abilities:
  • Demonstrated analytical and planning skills, together with the ability to take decisions and to translate those decisions into actions and priorities;
  • Demonstrate interpersonal skills including strong communication and negotiation skills;
  • Cultural sensitivity, open-mindedness and flexibility to work effectively in a dynamic multinational, matrix organisation;
  • Continuous improvement driven: Detects significant opportunities for improvement (cost, cycle time, process, quality, etc.). Analyses feasibility, participates and possibly leads in developing, executing, or monitoring implementation plan demonstrating strategic thinking as well as attention to detail.
  • Open to travel (EU and outside EU).

For further information on this Regulatory Affairs Specialist role in Limerick please contact Bimi Felix on 086 8395533 /

Check out all our open jobs on our HERO Recruitment website –
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Share this Job

“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 

Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King

Clients we are proud to work with