Regulatory Manager

Position: Regulatory Manager

Role Type: Permanent

Role Overview

We are supporting a Leading Disinfectant/Medical Sterilisation Manufacturer in the Essen region develop their Regulatory team in preparation for new portfolio production. The client we are supporting have been fundamental to SARS-CoV-2 prevention and overall medical instrument sterilisation across the EU.

The role requires a team first approach whilst having a hands-on attitude.

Responsibilities

· Design, review and submit Technical Dossiers under MDR (2017/745)

· Representative for external audits

· Prepare regulatory strategies and plans for approval of new portfolio

· Regular interaction with customers and external server providers

· Support/Coordinate technical departments (QA/RA)

· Monitor/report product approval status

· Regular interaction with Senior Management figures

Your Profile

· Completed Scientific or Engineering studies (BSc/MSc)

· Knowledge of working under and/or implementing systems related to MDR (2017/745)

· Several years within Quality Management or Regulatory Affairs

· Experience in EN ISO 13485 / EN ISO 14971

· Professional proficiency in German and English

What we offer

· Expanding Quality/Regulatory department

· Innovative product portfolio

· Clear progression pathway

· Competitive salary package