Freelance Regulatory Affairs Consultant
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Location
Berlin
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Sector:
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Job type:
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Salary:
Negotiable
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Contact:
Thomas Bithell
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Contact email:
t.bithell@ioassociates.eu
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Job ref:
BBBH158407_1746026711
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Duration:
6 months
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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.
