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Vacancy Details

Quality

QA and Regulatory Manager - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 6/05/2016
Job Reference: 82573

Job Description

Quality Assurance and Regulatory Affairs Manager


Our client, a leader in the aspect of research, design, development and manufacture of biomaterial solutions for medical implant products, are actively looking to recruit for an experienced RA and QA Manager for the plant in Galway.

Job Purpose:
This is a new role which has arisen within the organisation due to new business requirements. The successful candidate will have experience in dealing with Design Assurance and Regulatory Affairs for vascular products. This role will be reporting directly into the Chief Executive Officer and is responsible for maintaining and ensuring that the Company?s Quality Management System complies with FDA, ISO 13485 and international medical device regulatory standards.


Key Responsibilities:

  • To act as the point of contact for all regulatory communication in the company, including incident reports, audits, registrations, etc.
  • Establish, manage and maintain compliance with FDA QSR, including establishment registration, new product submissions, CAPA System.
  • Establish, manage and maintain compliance with MDD 93/42/EEC directive, including CE Mark applications via Technical Files.
  • Manage and maintain compliance to ISO13485 requirements.
  • Responsible for responding and reporting incidents to all approved markets.
  • Responsible for the Customer Complaint System.
  • Provide direct supervision, coaching and mentoring to engineers. This includes the areas of priorities, work directions objectives settings developmental opportunities and performance management work directions, objectives settings, developmental opportunities and performance management.
  • Manage the Quality Assurance and Regulatory department.
  • Develop annual goals and objectives for Design Assurance group ensuring they align with Cardiovascular Quality and CSH organizations.
  • Responsible for continuous improvement activities as determined in goals and objectives
  • Establish department goals, budgets, measurement and metric systems in line with business objectives to ensure quality standards are achieved and thus ensure that new product development projects are effectively managed.
  • Apply clinical knowledge of product use to ensure appropriate quality and design decisions are made and to support the development of bench simulations/tests to evaluate new product designs
  • Ensure all product evaluations from prototype testing to design verification are managed to the highest quality standards in compliance with corporate, regulatory and cGMP requirements.
  • Provide technical support and critical review to product development projects in problem solving and failure investigation and as required in the investigation of field returns.
  • Manage the preparation and submission of all necessary submissions (experience in PMA, 510(k) for the US, MDD requirements in Europe, and various global submission types is desirable)
  • Ensure compliance with current/emerging guidelines and regulations, and ensure appropriate policies and procedures are implemented.
  • Analyse regulatory guidance documents, anticipate the impact of changing regulations on development plans and regulatory strategies.




Education, Experience and skills
  • Honors Bachelor?s Degree/Masters in a relevant scientific or engineering discipline.
  • Minimum of 10plus years? experience in Quality Assurance and Regulatory affairs within the medical devices field of use.
At least 2 years management experience
  • Quality systems, quality operations knowledge & design assurance experience
  • The ability to identify regulatory problems of diverse scope and purpose solutions through collaboration and coordination with others.
  • Experience with FDA, Notified Bodies and/or International regulatory authorities is an advantage.
  • Strong verbal and written communication and influencing skills with good relationship building skills with coaching skills
  • Strong decision making and judgment
  • Change Management, excellent problem solving skills and results orientation.


For further information on this Regulatory and QA Manager job in Galway please contact Nicola O?Connell on 091730022 / Nicola@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


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

“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

“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
More

Clients we are proud to work with

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