Regulatory Affairs Lead – Freelance and Permanent! (US or EU)

Location:

Amsterdam – Noord-Holland, Nederland, Netherlands

Salary:

Negotiable

Type:

Permanent

Main Industry:

Search Science Jobs

Other Industries & Skills:

Chemistry, Physics, Life s

Advertiser:

NonStop Consulting

Job ID:

131639293

Posted On:

28 February 2025

Job Title: Regulatory Affairs Lead (Freelance or Permanent)
Location: Amsterdam, Netherlands
Industry: Medical Devices | Medical Software
Market: Regulatory Affairs

For an innovative medical software scale-up in Amsterdam we are seeking an experienced Regulatory Affairs Expert (RA FDA Lead) to drive FDA and MDR compliance This role offers a unique opportunity to lead a major FDA approval project, including a clinical study in the U.S. The position provides financial stability, the flexibility to work part-time (3 days per week) or full-time, and a long-term contract with remote work options, requiring travel to Amsterdam once or twice per month.

Key Responsibilities:

* Lead Regulatory Affairs activities for medical software, ensuring compliance with ISO 62304, MDR, and FDA requirements.
* Develop and execute regulatory strategies for MDR implementation and FDA submissions, including 510(k), PMA, and clinical trial approvals.
* Act as the primary liaison with the FDA, handling regulatory inquiries and inspections.
* Provide strategic input to cross-functional teams, ensuring compliance throughout the product lifecycle.
* Stay up to date with regulatory changes and guide internal stakeholders on compliance processes.

Qualifications & Skills:

* 8+ years of Regulatory Affairs experience in the medical device industry.
* Strong expertise in FDA submissions and medical software regulations (ISO 62304).
* Proven experience with MDR and FDA regulatory pathways, particularly for clinical studies in the U.S.
* Excellent communication, analytical, and project management skills.
* Fluent in English.

Benefits:

x2714; Long-term contract offering financial stability.
x2714; Flexible work arrangement (Freelance: 3 days/week or Permanent: Full-time).
x2714; Remote work, with travel to Amsterdam once or twice per month.
x2714; Work with a dynamic, fast-growing scale-up in cutting-edge medical software.

This is a fantastic opportunity for an experienced Regulatory Affairs leader looking to make an impact in the medical device and software space. If you’re ready to drive an FDA project and contribute to groundbreaking healthcare solutions, we encourage you !

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