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Vacancy Details

Science Pharmaceutical and Food

Senior Quality and Regulatory Assurance Specialist (QA/RA) - Cork

Contract Type: Permanent
Sector:
Location: Cork
Date: 31/05/2017
Job Reference: 87160

Job Description

Contact: Jenny Dore
Email: jenny@hero.ie
Telephone: 021 2066287




Senior Quality and Regulatory Assurance Specialist (QA/RA)


Who are the client

Our client, a medical device company in Cork are currently looking to recruit a Quality and Regulatory Assurance Specialist (QA/RA) for their site.

Why this role
  • Excellent package for the right person
  • Expanding company
  • Be part of a new team
  • Great location


What will I be doing
  • The Quality and Regulatory Assurance Specialist will be responsible for the development and maintenance of an ISO 13485 quality management system, preparing regulatory submissions and annual reporting for medical devices.
  • Manage all regulatory affairs activities in support of medical device product development, including clinical, preclinical, and marketing issues
  • Support planning, preparation, and submission of regulatory medical device submissions, including IDEs and 510(k)s
  • Provide strategic regulatory insight to team members regarding product development plans
  • Manage interactions with FDA and other regulatory authorities.
  • Monitor global regulatory trends and requirements impacting the development and commercialization of products, and advise colleagues and external partners to ensure compliance.
  • Participate in formulating strategies to optimize product approvals and opportunities of new and existing products, based on a broad understanding of regulatory requirements throughout the global marketplace for diagnostics and other medical device products
  • Maintain regulatory filings and compile all documentation needed for annual reporting and approval supplements
  • Managing the preparation of registration packages and responses to deficiency letters
  • Negotiating submission data requirements and deliverable dates with regulatory authorities and internal technical teams
  • Acting as a point person for regulatory agency interactions, including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products/teams
  • Evaluating manufacturing and labelling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations
  • Maintaining awareness of global regulatory legislation and assess its impact on business and product development programs
  • Implement, gain approval for and manage an ISO 13485 quality management system.
  • Main point of contact for notified body during certification and audits.
  • Keep abreast of changes in domestic and international Quality Systems regulations and guidelines, and advise key staff of compliance/non? compliance with current international regulations, policies and EC directives

What do I need
  • 4 years' experience in regulatory and quality affairs in a medical device company.
  • Thorough understanding and knowledge of FDA Quality System regulation, ISO 13485 and 21CFR820, ISO 14971, MDD (93/42/EEC).
  • Proven track record in writing major regulatory device submissions and the ability to successfully manage projects to deadlines
  • Experience working directly with regulatory agencies
  • Previous domestic/international submissions experience.
  • Experience of clinical trials a plus
  • Strong ability to manage critical projects as part of an interdisciplinary team
  • Excellent problem solving and communication skills
  • Must be self?motivated and detailed oriented
  • Excellent oral and written communication skills
  • Ability to work as part of multi?disciplinary team of clinicians, engineers and senior management
  • Regulatory Affairs Certification (RAC) is desirable.


For further information on this Quality and Regulatory Assurance Specialist (QA/RA) role in Cork please contact Jenny Dore on 021 2066287 / jenny@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

"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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