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Vacancy Details

Engineering & Technical

Senior Reg Affairs Specialist - Cork

Contract Type: Permanent
Sector:
Location: Cork
Date: 28/11/2018
Job Reference: 96109
Contact Name: Bimi Felix
Contact Email: bimi@hero.ie

Job Description

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

Senior Reg Affairs Specialist

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

Job Description / Information
  • Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes.
  • Supports the product lifecycle through to obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.
  • Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.
  • Viewed as regulatory team resource.
  • Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
  • Assisting in SOP development and review
  • Assisting in the development and update of regulatory strategy based upon regulatory changes
  • Providing regulatory input to new product development and product lifecycle planning
  • Evaluating regulatory impact of proposed changes to launched products
  • Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications
  • Determining and communicating submission and approval requirements
  • Participating in risk-benefit analysis for regulatory compliance
  • Continuing to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
  • Maintaining annual licenses, registrations, and listings
  • Ensuring compliance with product post-approval or clearance requirements
  • Approving labelling, advertising and promotional items for compliance before release
  • Reviewing publicly disseminated information to minimize regulatory exposure
  • Reviewing product claims and preserving confidentiality of applicable product information
  • Providing regulatory input for and appropriate follow-up to inspections and audits
  • Reviewing change management to determine the level of change and potential submission requirements
  • Identifying product-associated problems and developing proposals for solutions
  • Advising responsible personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications
  • Evaluating proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
  • Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements
  • Monitoring impact of changing regulations on submission strategies
  • Identifying issues early in the submission preparation process that could impact product launch
  • Compiling, preparing, reviewing and submitting regulatory dossiers to authorities
  • Participating in negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance
  • Ability to contribute to the resolution of routine regulatory issues using sound judgment
  • Ability to understand and explain detailed regulatory compliance programs and/or issues
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively
  • Ability to communicate and network with regulatory personnel to obtain relevant information

Minimum Qualifications
  • B.Sc. in Engineering, Sciences or equivalent preferred
  • 1-3 years regulatory experience in the medical device or pharmaceutical industry
  • RAC certification (preferred)
  • Knowledge of the Quality System Regulations (21 CFR), Medical Device Directives (MDD) and MEDDEV guidance
  • Knowledge of other regulations related to Pre Market Clearance and Post Market Support
  • Ability to work with cross functional teams
  • Ability to plan and conduct meetings
  • Ability to negotiate internally and externally with FDA, NB and other regulatory bodies
  • Excellent analytical and writing skills
  • Effective organizational skills

For further information on this Senior Reg Affairs Specialist role in Cork please contact Bimi Felix 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.

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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
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