Regulatory Affairs Manager

Negotiable
  1. Permanent
Frankfurt am Main (60488), Germany
  1. Regulatory Affairs, Operations
Posted: 03/07/2024
BBBH25747

Hobson Prior is seeking a Regulatory Affairs Manager for a role based in Frankfurt Am Main. This role will focus on managing regulatory affairs related to non-active implantable medical devices. The position is initially for 12 months.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

  • Prepare and submit applications for clinical trials of non-active implantable medical devices in the EU.
  • Compile and update product information texts according to company guidelines.
  • Maintain the CE mark by preparing and submitting applications for renewals, change notifications, annual updates etc.
  • Assess regulatory changes proposed by the production and marketing departments.
  • Coordinate regulatory projects and communicate with third parties concerning regulatory issues.
  • Develop regulatory strategies and participate in project teams.
  • Conduct due diligence for established products regarding regulatory aspects.

Requirements

  • A background in natural science or medical device engineering (pharmacist, biologist, chemist, etc.) with a diploma, master degree or PhD.
  • Knowledge of the European regulatory landscape.
  • Fluency in Business English is required, additional languages are a plus.
  • Proficiency in Microsoft Office.
  • Analytical and structured way of thinking.
  • Ability to network with internal and external stakeholders.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click Apply and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select Contact me at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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