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Vacancy Details


106501 - Regulatory Affairs Specialist II - Cork

Contract Type: Permanent
Location: Cork
Date: 16/01/2020
Job Reference: 106501
Contact Name: Clara Burke
Contact Email:

Job Description

Regulatory Affairs Specialist II - Cork - 106501
Regulatory Affairs Specialist II
Our client, a medical device company in Cork is currently looking to recruit a Regulatory Affairs Specialist II for their site.

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

  • Working as part of a team responsible for regulatory activities and issues occurring in the company. Includes review of Technical Files and providing information to US International Regulatory Affairs groups for other submission activities as well as regulatory issues relating to labelling, releases, and change orders.
  • Assist in preparation of Design Dossiers/Technical Files for all the products, in conjunction with divisional personnel and QA personnel.
  • Review and approve documentation related to product release.
  • Provide input, review and approve facility regulatory activities such as labelling.
  • 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.

Experience & Key Requirements
  • Minimum qualification required: BSC/BEng degree. Significant relevant experience may be considered in lieu of a primary degree.
  • Regulatory experience preferred but not essential
  • Minimum 3 years’ experience in a Health Care environment in a technical function
  • Experience in MDD, FDA, ISO, environment
  • Strong team member with the ability to identify and drive regulatory compliance improvements
  • Good administrative/organisational ability with excellent attention to detail
  • Excellent communication skills
  • Excellent analytical/decision making skills

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

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Chanelle Group

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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”. 

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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"

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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 

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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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