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Job Information

Regulatory Affairs Manager (Medical Device)

Information About this Role

Job Title: Regulatory Affairs Manager (Medical Device)

Location: Freiburg

Salary: Competitive Salary and Benefits

 

We have partnered with a Medical Technology Company who have had fantastic growth over the last 10 years and are now Market Leader in their therapy area (Orthopaedic rehabilitation). 

They require a Regulatory Manager to take them through Registration and approval within the EU. You will be working closely and interfacing with their R&D teams to lead the submission of required documentation. 

This is a fantastic opportunity to work hands-on with an inspiring technology.

Responsibilities

  • Coordinate and manage EU and RoW regulatory activities;
  • Develop RA strategies;
  • Provide strategic regulatory guidance for NPD;
  • Work closely with Design teams to plan, review, and approve required documents for filing to regulatory authorities; study protocols, investigator’s brochures, study reports and clinical evaluation reports;
  • Write summary documentation such as labeling, literature search summaries, safety and efficacy summaries, and technical summaries;
  • Manage communications and relationships with local authorities for specified projects;
  • Develop procedures for regulatory submissions and compliance activities for investigational and commercial processes;
  • Provide regulatory advice and guidance to product development for device changes;
  • Initiate submissions-related projects teams and track and manage their deliverables for regulatory submissions;
  • Maintain up-to-date knowledge of regulatory requirements; and

Experience Required

  • Regulatory CE Registrations  (Medical Device or Pharma)
  • Compilation and submission of Technical Files
  • Ability to work autonomously
  • Experience with NEW Product Registrations and experience working with Design Teams

 

If you are curious about this exciting opportunity as a Regulatory Affairs Manager APPLY NOW and change your life today.

For more information about the role call Matthew for a confidential chat on 0203 8000 518 or email me on kieran@projectusconsulting.com.

Due to high demand, only successful applicants will be contacted. A consultant will reach you within 7 working days.

Projectus is the world leader in medical technology talent management.

Our sole mission is to connect medical technology companies with the best industry professionals across the globe. We place people across the full medical device spectrum including R&D, Regulatory, Engineering, Sales, Marketing, Clinical and Service.

For all our services visit www.projectusconsulting.com and discover more.