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Vacancy Details

Quality

Senior Regulatory Affairs Specialist - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 28/11/2018
Job Reference: 100277
Contact Name: Bimi Felix
Contact Email: bimi@hero.ie

Job Description

Contact: Bimi Felix
Email: recruit@hero.ie
Telephone: 086 8395533

Senior Regulatory Affairs Specialist

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

Description
At our Regulatory Affairs department focus on ensuring that all our products comply with Global Regulations and International Standards, across the Ventilation portfolio. As a Senior Regulatory Affairs Specialist, you will be responsible for managing regulatory submission activities for product maintenance for existing approved products.
  • Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
  • Prepare FDA submissions and CE Mark Technical Files for product changes and/or new products as required to ensure timely approvals for market released products.
  • The completion and management of MDR activities/remediation as required by the business product portfolio.
  • Provide support to currently-marketed products as necessary. This includes reviewing product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status. Interact directly with FDA and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
  • Maintain and update Insight database (used for tracking Worldwide Product Registrations)
  • Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
  • Ensure personal understanding of all quality policy/system items that are personally applicable.
  • Follow all work/quality procedures to ensure quality system compliance and high-quality work.


Qualifications
  • Bachelor’s Degree level 8 (No equivalencies)
  • 4+ years industry experience Quality Assurance or Regulatory Affairs for a Medical Device or Pharmaceutical Industry.
  • Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13483/MDD and MDR) and/or Pharmaceutical GMP (21 CFR 210/211).
Desired
  • 4+ years regulatory submission experience and management of technical files for medical devices
  • Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
  • Experience with international standards (ISO, GHTF, ICH).
  • Experience with FDA and international regulatory agency requirements, CE marking (AIMD and MDD).
  • Experience with medical devices (510(k), PMA), pharmaceuticals, or combination products (drug/biologic-device).
  • Experience working with cross-functional teams.
  • Experience working with technical documentation.
  • Project management skills. Product development experience.
  • Knowledge of procedures and systems.
  • Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment.
  • Strong oral and written communication skills.
  • Effective interpersonal skills. Effective team member.
  • Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
  • Ability to effectively manage multiple projects and priorities.
  • Proficient skills with MS Word, MS Outlook, MS Excel.


For further information on this Senior Regulatory Affairs Specialist role in Galway please contact Bimi on 086 8395533 / recruit@hero.ie

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

Clients we are proud to work with

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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,
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
Valeo

“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
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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,
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
Valeo

“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
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Clients we are proud to work with

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