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Vacancy Details

Science Pharmaceutical and Food

Senior Specialist, Global Post-Market Surveillance - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 12/07/2018
Job Reference: 95740

Job Description

Contact: Jenny Dore
Email: jenny@hero.ie
Telephone: 086 0449371



Senior Specialist, Global Post Market Surveillance
Our client, a medical device company in Galway are currently looking to recruit a Post Market Surveillance Senior Specialist for their site.

What will I be doing

  • The Global Senior Specialist role will work with the Director, Global Post-Market Surveillance to oversee global complaint management and post-market regulatory reporting activities for the Diagnostics division. This role will report directly to the Director, Global Post-Market Surveillance.
  • Assist in the development and maintenance of global standards, policies, and procedures related to complaint handling and post-market adverse event reporting in accordance with 21 CFR Part 820.198, 21 CFR Part 803, ISO 13485, MEDDEV 2.12-1 and others.
  • Assist in the establishment and implementation of global complaint management and adverse event reporting strategies
  • Support and/or lead recurring Initial Complaint Intake and Complaint Entity site stakeholder team meetings
  • Support site audits as necessary to ensure effective implementation of global standards and procedures related to complaint management and adverse event reporting
  • Provide subject matter expert (SME) guidance to Diagnostics sites regarding regulations associated with complaint management and adverse event reporting
  • Provide SME guidance to the development teams in support of the change management process for the global complaint intake and complaint management technology solutions
  • Carry out duties in compliance with established business policies
  • Demonstrate commitment to the development, implementation and effectiveness of the division Quality Management System per ISO, FDA, and other regulatory agencies
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices
  • Perform other duties & projects as assigned


What do I need
  • Bachelor's degree in related field (Science or engineering preferable)
  • A minimum of 8 years working in a regulated medical device complaint management function
  • Strong background in complaint management process definition and compliance discipline
  • Expert knowledge of US and global regulations related to medical device complaint handling and regulatory reporting in accordance with 21 CFR Part 820.198, 21 CFR Part 803, ISO 13485, MEDDEV 2.12-1 and others.
  • Experience working in electronic complaint management systems
  • Excellent verbal and written communication skills, able to convey appropriate information with clarity and effectiveness.
  • Excellent computer skills including all MS Office applications
  • Able to travel internationally (approximately 10% annually)
  • Experience supporting in-vitro diagnostics products
  • Experience managing a global complaint handling functional group for medical device or in-vitro diagnostics
For further information on this Global Post Market Surveillance role in Galway please contact Jenny Dore on 086 0449371 / 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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“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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“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,
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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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“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,
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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"

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