Tech & Digital

Freelance Regulatory Affairs Consultant

  • Location

    Berlin

  • Sector:

    Information & Cyber Security

  • Job type:

    Contract

  • Salary:

    Negotiable

  • Contact:

    Thomas Bithell

  • Contact email:

    t.bithell@ioassociates.eu

  • Job ref:

    BBBH158407_1746026711

  • Duration:

    6 months

  • Startdate:

    ASAP

Freelance Regulatory Affairs Consultant - Medical Devices (Berlin, Remote-Friendly)
Location: Berlin, Germany (with flexibility for remote work)
Contract Type: Freelance / Contractor- 6 months with possibility of extension
Industry: Medical Devices
Start Date: ASAP

IO Associates are delighted to support a leading and innovative medical devices company is seeking an experienced Freelance Regulatory Affairs Consultant to support regulatory compliance and strategic submissions under EU MDR and global frameworks.

Key Responsibilities:

  • Provide expert regulatory guidance throughout the product lifecycle.
  • Prepare and review technical documentation for CE marking and global submissions.
  • Advise cross-functional teams on compliance with EU MDR and related standards.

Requirements:

  • Minimum 3 years of regulatory affairs experience in the medical devices sector.
  • Strong knowledge of EU MDR (2017/745) and ISO 13485.
  • Experience with Class IIa, IIb, or III devices preferred.

On Offer:

  • Flexible working arrangements (remote or Berlin-based).
  • Competitive daily rate based on experience.
  • Opportunity to support innovative medical technologies in a collaborative environment.

Interested?
Send your CV and availability to All applications will be treated confidentially.