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Vacancy Details

Administration

IT/Software

Reg Affairs Manager in Limerick - Limerick Cork Kerry

Contract Type: Temporary
Sector:
Location: Limerick Cork Kerry
Date: 25/04/2016
Contact Name: Nicola
Contact Email: nicola@ccprecruit.ie

Job Description

Reg Affairs Manager
Our client, a leading medical device organisation, are looking to recruit a RA Manager. This role can be based in their plant in Cork or in Limerick. The successful candidate will work across both Regulatory and Project teams across to develop and maintain a strategic plan for the organisations sustaining product portfolio, including all global submissions, projects & activities.
 
Duties:
The RA Manager will be responsible for developing, modifying, and executing regulatory related company guidelines and procedures. You will work alongside with other Regulatory leaders within the Division to ensure consistency in approaches across the business units.
Lead a regulatory team and help build a high trust and positive engagement work environment.
Agree objectives, provide regular feedback and manage performance to ensure implementation of regulatory plans and service.
Create training plans and co-ordinate training of Regulatory Affairs team members
The RA Manager will be responsible for assuring that the FDA regulatory requirements and any other applicable government or international standards are implemented and maintained. Take lead on responses to additional information requests from Global Regulatory Agencies. Maintaining annual licenses, registration and listing information
Co-ordinate product field action communications internally and externally. Track and report on product field action progress and completion.
Ensure the timely close out of audit actions and departmental NC/CAPAs
Co-ordinate adverse event filings, including MDR and MDV reports in accordance with applicable regulations. Ensure changes are correctly assessed through the Regulatory Assessment process and the impact of cumulative changes are assessed.
Utilize risk management process to determine potential and actual risk related to complaint events. Identify and present options for risk mitigation to decision makers
Provide strategic and technical guidance on regulatory requirements to the regulatory and operations teams when requested. Evaluating risk of and regulatory solutions to product and clinical safety issues and recommend solutions
Evaluate proposed manufacturing changes for regulatory filing strategies
Research and participate in industry working groups and committees
Lead and involve team in implementing continuous improvement projects
 
Education & Experience:
Bachelor Science in Engineering, Sciences or equivalent preferred
5+ years demonstrated regulatory affairs experience or equivalent
Knowledge of the Code of Federal Regulations, ISO 13485, MDD, Japanese and Canadian Regulations, Quality System Regulations (21 CFR) and other regulations related to Pre Market Clearance/Approval.
Ability to rapidly build product knowledge and understanding of highly technical and scientific regulatory activities
 
For further information on this Reg Affairs Manager role in Cork or Limerick please contact Nicola O’Connell on 091730022 / nicola@ccprecruit.ie
Check out all our open jobs on our CCP Recruitment website – www.ccprecruit.ie
 
Please Note: CCP Recruitment will not forward your details to any company without your prior approval

Clients we are proud to work with

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Moira Faherty,
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“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”.

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"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"

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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
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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,
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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,
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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”. 


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Ingersoll Rand – Thermo King
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Clients we are proud to work with

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