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Regulatory Affairs Manager (f/m/d) Freelance - Medical Devices

  • Location: Baden-Württemberg
  • Salary: Negotiable per day
  • Job Type:Contract

Posted 25 days ago

  • Sector: Medical Technology
  • Contact: Liana Costanza
  • Contact Email: l.costanza@sciproglobal.de
  • Expiry Date: 08 July 2022
  • Job Ref: RA_2022_1_1654693085

Regulatory Affairs Manager (f/m/d) - Freelance | Medical Devices

Start: immediately - up to 80% remote

As a Freelance Regulatory Affairs Manager (f/m/d) you will be responsible for bringing medical devices to the EU market and supporting global regulatory approvals for a renowned medical devices manufacturer in Baden-Württemberg.

Your tasks:

  • Implementation of the requirements of worldwide approvals of our leading medical products
  • Coordination and execution of regulatory activities for the development programs
  • Development and implementation of regulatory strategies
  • Management, coordination, and compliance of technical documentation for international approval of medical devices, considering country-specific requirements
  • Preparation of and compliance with approval plans
  • Regulatory review and evaluation of product changes
  • Work closely with cross-functional teams to bring products to market quickly and efficiently
  • Contribute to the development of the product development and change process
  • Participation in CAPA's
  • Timely application and implementation of regulatory requirements

Your profile:

  • Successfully completed studies in natural sciences or comparable qualification
  • Team spirit, open communication, integrity, flexibility, commitment, and willingness to learn
  • 2+ years of professional experience in the approval of medical products

Additional knowledge:

  • Knowledge of MDR and other regulatory requirements
  • Basic Knowledge in compliance engineering
  • Experience with studies, risk assessment
  • Experience in medical device development
  • Advanced English skills