Connecting to LinkedIn...

Vacancy Details


106703 - Senior Regulatory Affairs Specialist – Post Market - Limerick

Contract Type: Permanent
Location: Limerick
Date: 30/06/2020
Job Reference: 106703
Contact Name: Clara Burke
Contact Email:

Job Description

Senior Regulatory Affairs Specialist – Post Market - Limerick - 106703
Senior Regulatory Affairs Communications Specialist – Post Market

The Senior Regulatory Affairs Communications Specialist – Post Market (Adverse Event Reporting & Field Actions) supervises and manages a team of RA specialists with responsibility for the Adverse Event Reporting and Field Action for all devices.

Reporting to: Regulatory Affairs Manager

  • Responsibility for implementing regulatory requirements for adverse event reporting and field action in accordance with ISO13485, MDD 93/42/EEC, EU MDR 2017/745 and FDA 21CFR Parts 806, 803, 820 and other jurisdictions as required.
  • Supervise and manage a team of Regulatory Affairs Communications Specialists: managing day-to-day workload and operational issues. Set team objectives and monitor performance. Provide coaching and support and acting as a point of escalation where necessary.
  • Ensure that complaints are assessed for Regulatory Reporting; this includes Adverse Event Reporting (MDR, Vigilance, etc.) and associated correspondence to applicable Regulatory bodies including peer review of same.
  • Review and approve Adverse Event Reports that are generated by the team prior to submission to relevant Competent Authority / Regulatory Authority.
  • Ensure all reports are submitted within the required timeframes for adverse event reporting and field actions.
  • Conduct the AE re-assessment of all complaints when additional information is received.
  • Conduct regulatory review and assessment of trends and submission of trend reports where relevant.
  • Conduct the manufacture final review and send files to Customer Relations team for closure.
  • Co-ordinate the weekly regulatory reporting requirements with the Quality Engineering function. Ensure metrics for this area are monitored and reported to management when necessary.
  • Conduct Health Risk Assessment (HRA) regulatory reporting assessments as necessary in relation to any potential issues that may lead to a field action.
  • Draft / review of any Field Safety Notices (FSNs), Field Safety Corrective Actions (FSCAs), Customer Letters, Global Recall Documentation and liaising with local Customer Relations, Affiliates and/or Distributors as required.
  • Recall co-ordination (including Competent Authority responses) – Global and Local as appropriate.
  • Serve as a liaison on regulatory issues between the Manufacturer and the Affiliates and/or Distributors.
  • Participate in internal and external audits as Subject Matter Expert in Adverse Event Reporting and Field Action.
  • Provide support for Post Market Surveillance, Clinical Evaluation Reports and Regulatory Marketing Authorization submissions by providing summary adverse event and field action information when required.
  • Review and approve Post Market Surveillance, Post Market Clinical Follow Up and Clinical Evaluation activities as required.
  • Report relevant information in Management Review.
  • Actively pursues ways in which to improve the function of the Regulatory Affairs Department supporting continuous improvement activities.
  • Third level Qualification in Science/Quality preferred.
  • 5 years’ + experience in a regulated industry in a similar role desired.
  • Ideally have knowledge of requirements in MDSAP countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU MDR 2017/745 and FDA QSP 21CFR Part 820 as required.
  • Knowledge of requirements in other jurisdictions where required.
  • Knowledge of medical device quality standards/practises or similar regulated industry.
  • Previous experience in using Trackwise or equivalent complaints handling system.
  • Proven decision-making capabilities & problem-solving skills.
  • Good communication and inter-personal skills.
  • Good computer skills including knowledge of Microsoft®
  • Proven organisational skill & high level of self-motivation.
  • Willingness and availability to travel on company business as required.

For further information on this Regulatory Affairs Manager role in Limerick please contact Clara Burke on 086 8168273/

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

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

Nikhil Pradeepkumar
Optical Engineer
Valeo Vision Systems

Clients we are proud to work with