Connecting to LinkedIn...

Vacancy Details

Engineering & Technical

Senior Regulatory Affairs Specialist - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 1/10/2017
Job Reference: 89939

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 0868395533

Senior Regulatory Affairs Specialist
Our client, a medical device company in Galway are currently looking to recruit a Senior Regulatory Affairs Specialist for their site.


Our Offer
  • You will be responsible for reviewing clinical protocols to be used in submissions.
  • Preparing, reviewing and filing appropriate FDA per market submission to ensure devices are commercially available in the U.S.: preIDEs, IDEs, 510(k) s, PMAs and PMA Supplements.
  • You will represent RA as core team member to drive innovation on Tech. Dev. Projects and follow through to market release.
  • You will support Design Control process.
  • Prepare Rational to file documentation for modifications to devices when appropriate.
  • You will participate in FDA & other notified body Inspection.
  • You will communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management.
  • You will develop and maintain Regulatory Strategies for new or modified products and prepare project plans & budgets.
  • Monitor and provide management with impact of changes in the Regulatory environment.
Qualifications
Your Profile
  • We are looking for a qualified person to Bachelor's degree level in Engineering, scientific, or technical discipline.
  • 6+ years of Regulatory/Quality experience, 2+ years of medical device experience or relevant experience.
  • You are a dynamic team player and can work effectively and proactively on cross-functional teams.
  • You are experienced with U.S. and/or European/International regulations and standards; Experienced in preparing regulatory submissions; interacting with FDA and/or other regulatory agencies.
  • Provide a significant breadth of knowledge in Quality, project planning, technical expertise, and all areas of product development.
  • Have knowledge of FDA regulations and TUV requirements.
  • You have a strong collaborative mindset to create alignment with cross functional players.
  • You are decisive with an ability to initiate and lead change.
  • You are a good communicator and fluent in English, both in writing and speaking.
  • Leadership Expectations provide the framework for what we expect from all employees at the company - outlining the actions and behaviours we must develop and demonstrate in pursuit of our Mission and global growth goals.
For further information on this Senior Regulatory Affairs Specialist role in Galway please contact Bimi Felix on 0868395533 / bimi@hero.ie
Check out all our open jobs on our HERO Recruitment website - www.hero.ie
Please Note: HERO Recruitment will not forward your details to any company without your prior approval

Share this Job

Our Clients

With a reputation across three decades in the making, HERO Recruitment continues to impress our clients and candidates with our passion and dedication to our craft.

See More

What people say

Our strong reputation for quality placements in key roles has earned us the status of agency of choice. HERO Recruitment’s commitment to superior service is what sets us apart from our competitors and has rewarded us with many exclusive and semi-exclusive client and candidate relationships.  Here is what our clients and candidates say about us…

See More

“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

“Merit Medical have partnered with Hero for the past 10 years. During this time we have grown our employee numbers to 630 employees. Our experience of working with HERO is that they have a personal client focused approach, they know the market and they can deliver on the candidates.  The medical device market is competitive and our company success is dependent on the quality of our people, we want the best there is in the market so we can grow and in turn offer development opportunities to our people. 

Mary Collins,
Senior Director, Human Resources Europe
Merit Medical

“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
Pivot

“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