Regulatory Subject Matter European Lead - Devices and Equipment (all genders)

Posted 28 Apr 2020

Darmstadt, Hesse - Germany

Req Id 205476

Details

A career at our company is an ongoing journey of discovery: our around 56,000 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: An exciting new opportunity has arisen to join our company as Regulatory Subject Matter Expert (all genders). Besides providing subject matter expertise, you lead the EU based regulatory team. Your role is about implementing global regulatory strategies and oversighting of required regulatory submissions and product registrations/licensing for new products. You act as SME contact with business fields to understand and support the strategy, provide regulatory expertise and advocacy. You are responsible for regulatory reviews of document changes, deviations and printed materials to ensure all necessary regulatory requirements are met. You write and maintain procedures relating to the Regulatory management, the preparation and presentation of quality reports, data and Key Performance Indicators for management reviews. You bridge between site and notified body or other regulatory authorities. You take care about the surveillance of global regulation impacting IVDs and reporting of changes/new regulations to ensure compliance. You provide regulatory training and support to departments to ensure regulatory requirements on company’s products are understood.

 

Who you are:

  • University Degree in a quality or science related discipline (Post graduate degree preferred)
  • Professional experience working within the IVD or medical device industry at management level
  • Expertise in 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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