Freelance Regulatory Affairs Consultant

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.