Regulatory Affairs Subject Matter Expert II

Posted 04 Dec 2019

Carrigtwohill, Munster - Ireland

Req Id 198043

Details

A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your role:  Provide regulatory support to the Cork manufacturing site product portfolio of Medical and IVD Devices products and provide subject matter expertise support for strategic projects and supporting of other Medical device manufacturing sites within EU as required.

  • Supporting the implementation global product registration and listing activities. Responsible for required regulatory submissions and product registrations/licensing for new products with either directly (for example in EU, US and Canada) or indirectly working with regional regulatory groups and or third-party representatives.
  • Support the implementation of strategic regulatory projects and initiatives including transition project to new regulatory requirements i.e. EU medical device and IVD regulations and new product development projects.
  • Support and implementation of any required regulatory re-certification or annual re-listings, updates and reports for regulated products.
  • Responsible for the review of change controls relating to regulated products and liaising with regional regulatory organizations to ensure any required regulatory change notifications/reporting or new submissions are carried out.
  • Responsible for the review of complaints and participating in risk assessments to determine regulatory vigilance requirements. 
  • Responsible for authority vigilance reporting either directly or liaising with regional regulatory groups or third-party representatives to facilitate vigilance reporting.
  • Responsible for regulatory review of document changes, deviations and printed materials as required to ensure all necessary regulatory requirements are met.
  • Act as liaison and correspondent between site and regulatory authorities such as EU Notified Bodies, US FDA, Health Canada etc.
  • Assemble and maintain technical files, device master records and other regulatory documentation to ensure current, and changes recorded. 
  • Review of updated standards and regulations, carry out documented review, ensuring any necessary updates are made and disseminating information throughout the site. 
  • Support preparation of and participate in any regulatory audits by regulatory authorities. 
  • Support preparation of and participate in any customer audits which require regulatory input. 
  • Responsible for answering customer (internal & external) regulatory requests or enquiries. 

 

Who you are:

  • A regulatory affair professional with experience working within the medical/IVD device industry.
  • Undergraduate Degree in a quality or science/engineering related discipline.
  • Good working knowledge of Medical device/IVD regulations within EU and NA, working knowledge of global medical device/IVD regulations.
  • Motivated, meticulous individual with excellent organisational, communications and technical writing skills.
  • Proven track record of organising work-load and activities to meet required deadlines.

 


What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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