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Vacancy Details


106732 - Regulatory Affairs Specialist II - Galway

Contract Type: Permanent
Location: Galway
Date: 21/02/2020
Job Reference: 106732
Contact Name: Clara Burke
Contact Email:

Job Description

Regulatory Affairs Specialist II - Galway - 106732
Regulatory Affairs Specialist

My client a medical device company in Galway is looking to hire a Regulatory Affairs Specialist for their site on a permanent basis

Responsible for Regulatory Affairs support of the product development process, submissions, maintenance of regulatory files and regulatory compliance.

Key Responsibilities
  • Working as part of a team responsible for Regulatory Activities and issues occur.
  • Reviews change requests to support maintenance of product technical documentation
  • Supports sustaining projects and teams on giving direction on regulatory impact on proposed changes. This involves liaison with International countries for impact decisions.
  • Assist in preparation and maintenance of Design Dossiers/Technical Files for all products, prepares and submits US regulatory submissions such as 30 Day notices, co-ordinates responses to same in a timely manner.
  • Participates in Regulatory Body audits such as FDA & DEKRA.
  • Provide input, review and approve facility regulatory activities such as labeling.
  • Provide Emerging Markets submissions information to U.S. based and Emerging Markets based International Regulatory Affairs personnel for all products.
  • Provide updates on regulatory requirement changes, either on individual product specification or quality systems. Understands and proactively follow through on the Environmental Management Procedures that have been identified as relevant to position.
  • Work with the Regulatory group in converting EU MDD files to comply with MDR 2017/745.

Quality System Requirements
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.

  • Minimum qualification required: BSC/BEng degree. Significant relevant experience may be considered in lieu of a primary degree.
  • Minimum 3 years’ experience in a similar environment in a technical function
  • Regulatory experience preferred but not essential
  • Experience in MDD, FDA, ISO, environment

For further information on this Regulatory Affairs Specialist II role in Galway please contact Clara Burke on 086 8168273 /

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“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,
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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”.   

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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”.

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VP of Human Resources

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Orla Keady-Giblin,
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Ingersoll Rand – Thermo King

I am extremely grateful to Anne-Marie at HERO Recruitment for helping me land an opportunity in Ireland. She had a great deal of information regarding the job profile, was extremely prompt in arranging an interview and followed it up brilliantly. She was an excellent point of contact between the employer and me during the whole process. She has good knowledge about the process and was well aware of the timelines. I would recommend Anne-Marie, HERO Recruitment to anyone who is looking for opportunities in the country

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