Regulatory Affairs Team Lead

  • Location

    Karlsruhe, Germany

  • Sector:

    Regulatory Affairs

  • Salary:

    €90,000

  • Contact:

    Rebecca Stevens

  • Job ref:

    18062

  • Published:

    about 1 year ago

  • Expiry date:

    2020-06-08

Regulatory Affairs Team Lead (m / w / d)

Based in Baden-Wurttemberg, near Karlsruhe

Our client is a global leader in medical devices for critical care, surgical and lifesaving treatments. Due to medical device product expansion and the new European regulations, they are growing the regulatory team to include a Regulatory Affairs Team Manager who will focus on European registrations, and touchpoints to the FDA. With offices in more than 35 locations worldwide and a sophisticated portfolio of devices, the opportunity for development and autonomy is clear and is an exciting challenge for a Regulatory Affairs Leader.

Candidates who do not have previous leadership experience but ready for the step up and challenge, please do apply as your application will be seriously considered. 

Your Responsibilities:

  • Leading a team of 5+ regulatory affairs professionals and providing strategic direction for approvals processes
  • Strategic preparation and processing of global regulatory approvals for market-leading medical products
  • Device launches in EU/USA under the MDR and FDA
  • Collaborate on risk management for medical devices under ISO 14971 and review technical documentation files 
  • Development and execution of regulatory strategies
  • A close partnership with other departments for a quick and efficient product launch in multiple markets

Experience Required:

  • Degree educated in scientific studies or engineering
  • 4+ years of experience in regulatory affairs at a medical device company with complex products (ie - active/electrical or implantable, high risk)
  • Working knowledge of the MDD/MDR, FDA as a bonus
  • Very good spoken German and written English
  • Technical experience in engineering or quality management is a plus

 

Please apply with your CV or contact the job poster Rebecca Woodfield for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.

Rebecca.Woodfield@Adaptivelifescience.com

+44 208 638 5376