Regulatory Affairs Subject Matter Expert

Posted 25 Oct 2019

Scotland - all, Scotland - United Kingdom

Req Id 197513

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: To provide regulatory support and leadership to the Livingston manufacturing site product portfolio of IVD and intermediate biologic products and provide subject matter expertise for projects and business support. Manage, plan and implement 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, plan and implement strategic regulatory projects and initiatives including new product introduction. Act as SME contact with business fields – working with Business to understand support strategy, provide regulatory expertise and advocacy. Responsible for any required regulatory re-certification or annual re-listings, updates and reports for regulated products. Responsible for reviewing 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 reviewing complaints and participating in risk assessments to determine regulatory vigilance requirements. Responsible for carrying out 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.  Write and maintain procedures relating to the Regulatory management function, the preparation and presentation of quality reports, data and Key Performance Indicators for management reviews. Act as liaison between site and notified body or other regulatory authorities. Surveillance of global regulation impacting IVDs and reporting of changes/new regulations to ensure compliance. Provide regulatory training and support to departments as needed to ensure regulatory requirements as applied to the Company’s product(s) are understood

 

Who you are:

  • A regulatory affair professional with at least 5 years’ (10 years preferred) experience working within the IVD or medical device industry.
  • Undergraduate Degree in a quality or science related discipline (Post graduate degree preferred)
  • Expert knowledge/experience of Medical device/IVD regulations within Europe and North America.
  • Working knowledge of global Medical device/IVD regulations.
  • Experienced, innovative, and motivated with demonstrated leadership skills.
  • Proven track record of participation and leadership within major regulatory projects involving multiple cross-functional departments and 3rd parties.

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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